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    <description>Life sciences, under the hood. Deep dives into the patent filings, regulatory gauntlets, and capital-risks that shape the business of biology.</description>
    <copyright>Alex Kesin</copyright>
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    <itunes:summary>Life sciences, under the hood. Deep dives into the patent filings, regulatory gauntlets, and capital-risks that shape the business of biology.</itunes:summary>
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      <title>Episode #2: Geron</title>
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      <itunes:title>Episode #2: Geron</itunes:title>
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        <![CDATA[<p>Listen on <a href="https://open.spotify.com/episode/4COpXyTfI7jifq6da7wM52?si=EHI93INORPWlX8CabI6wcg">Spotify</a></p><p>Listen on <a href="https://podcasts.apple.com/us/podcast/episode-2-geron/id1873356046?i=1000755117965">Apple Podcasts</a></p><p>Listen on <a href="https://www.youtube.com/watch?v=ryeqeon5y4s">YouTube</a></p><p><strong>TABLE OF CONTENTS</strong></p><p>(00:00:00) - Introduction </p><p>(00:01:19) - Hayflick Limit </p><p>(00:08:30) - Michael West &amp; Founding of Geron </p><p>(00:15:16) - Early Science &amp; IP Strategy </p><p>(00:27:25) - Cloning the Telomerase Gene </p><p>(00:29:30) - Embryonic Stem Cells &amp; Political Context </p><p>(00:44:21) - Okarma, West’s Departure &amp; Corporate Turmoil </p><p>(01:05:08) - Spinal Cord Injury Trial </p><p>(01:30:45) - Pivot to Blood Cancer </p><p>(01:43:08) - Clinical &amp; Commercial Drama</p><p>(02:01:45) - Legacy &amp; Lessons</p><p><strong>CREDITS</strong></p><p>Co-hosted by Alex Kesin and Matthew Pech</p><p>Written, edited, and produced by Alex Kesin</p><p>Music: <a href="https://www.youtube.com/watch?v=4PoCA4taNyg">“Food”</a> by nerowski</p><p>* Special thanks to the team at <a href="https://www.nfx.com/">NFX</a> for the use of their recording studio.</p><p><strong>SOURCES</strong></p><p><strong><em>Last updated: March 2026</em></strong></p><p><strong>I. BOOKS</strong></p><p><a href="https://www.amazon.com/Merchants-Immortality-Pa-Stephen-Hall/dp/0618492216">Hall, Stephen S. <em>Merchants of Immortality: Chasing the Dream of Human Life Extension.</em> Houghton Mifflin, 2003.</a></p><p><a href="https://www.amazon.com/Inevitable-Collision-Inspiring-Research-Conservative-ebook/dp/B00NGRMSHC">Williams, Tory. <em>Inevitable Collision: The Inspiring Story That Brought Stem Cell Research to Conservative America.</em>Mary Ann Liebert, Inc., 2014.</a></p><p><strong>II. KEY SCIENTIFIC PUBLICATIONS</strong></p><p><a href="https://pubmed.ncbi.nlm.nih.gov/13905658/">Hayflick, L. &amp; Moorhead, P.S. “The serial cultivation of human diploid cell strains.” Experimental Cell Research 25 (1961): 585–621.</a></p><p><a href="https://pubmed.ncbi.nlm.nih.gov/7605428/">Kim, N.W. et al. “Specific association of human telomerase activity with immortal cells and cancer.” Science 266, no. 5193 (1994): 2011–2015.</a></p><p><a href="https://pubmed.ncbi.nlm.nih.gov/7544491/">Feng, J. et al. “The RNA component of human telomerase.” Science 269, no. 5228 (1995): 1236–1241.</a></p><p><a href="https://www.science.org/doi/10.1126/science.277.5328.955">Nakamura, T.M. et al. “Telomerase catalytic subunit homologs from fission yeast and human.” Science 277, no. 5328 (1997): 955–959.</a></p><p><a href="https://www.cell.com/cell/pdf/S0092-8674(00)80538-3.pdf">Meyerson, M. et al. “hEST2, the putative human telomerase catalytic subunit gene, is up-regulated in tumor cells and during immortalization.” Cell 90, no. 4 (1997): 785–795.</a></p><p><a href="https://www.science.org/doi/10.1126/science.279.5349.349">Bodnar, A.G. et al. “Extension of life-span by introduction of telomerase into normal human cells.” Science 279, no. 5349 (1998): 349–352.</a></p><p><a href="https://www.science.org/doi/abs/10.1126/science.282.5391.1145">Thomson, J.A. et al. “Embryonic stem cell lines derived from human blastocysts.” Science 282, no. 5391 (1998): 1145–1147.</a></p><p><a href="https://pubmed.ncbi.nlm.nih.gov/12873987/">Asai, A. et al. “A novel telomerase template antagonist (GRN163) as a potential anticancer agent.” Cancer Research 63, no. 14 (2003): 3931–3939. </a></p><p><a href="https://pubmed.ncbi.nlm.nih.gov/15940257/">Herbert, B-S et al. “Effect of the lipid modification of GRN163.” Nature: Oncogene 24 (2005): 5765–5772. </a></p><p><a href="https://www.nejm.org/doi/full/10.1056/NEJMoa1503479">Baerlochr, G. et al. “A pilot study of the telomerase inhibitor imetelstat for myelofibrosis.” New England Journal of Medicine 373 (2015): 908–919. </a></p><p><a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01724-5/abstract">Platzbecker, U. et al. “Imetelstat in patients with lower-risk myelodysplastic syndromes who have relapsed or are refractory to erythropoiesis-stimulating agents (IMerge).” The Lancet (2024).</a></p><p><a href="https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.70076">Lennox, A.L et al. “Imetelstat, a novel, first-in-class telomerase inhibitor: Mechanism of action, clinical, and translational science.” <em>Clinical and Translational Science</em> 17, no. 11 (2024).</a></p><p><a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC4250218/">Scott, C. &amp; Magnus, D. “Wrongful Termination: Lessons From the Geron Clinical Trial” Stem Cell Reports 3, no. 5 (2014): 721–723. </a></p><p><strong>III. REGULATORY &amp; CLINICAL</strong></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217779s000lbl.pdf">Prescribing Information (Label) U.S. Food and Drug Administration. “RYTELO (imetelstat) for injection: Highlights of Prescribing Information.” NDA 217779. June 2024. </a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217779Orig1s000ltr.pdf">NDA Approval Letter U.S. Food and Drug Administration. “NDA Approval Letter: RYTELO (imetelstat) for injection.” NDA 217779. June 6, 2024. </a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217779Orig1s000OtherR.pdf">Multi-Discipline Review &amp; Evaluation U.S. Food and Drug Administration. “NDA Multi-Disciplinary Review and Evaluation: RYTELO (imetelstat).” NDA 217779Orig1s000. 2024. </a></p><p><a href="https://www.fda.gov/media/176966/download">ODAC Briefing Document U.S. Food and Drug Administration. “FDA Briefing Document: Oncologic Drugs Advisory Committee Meeting, NDA 217779, Imetelstat.” March 14, 2024. </a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217779Orig1s000RiskR.pdf">REMS/Risk Assessment Review U.S. Food and Drug Administration. “Risk Assessment and Risk Mitigation Review: RYTELO (imetelstat).” NDA 217779Orig1s000. 2024. </a></p><p><a href="https://ascopubs.org/doi/abs/10.1200/JCO-25-01369">Kim, N. et al. “US Food and Drug Administration Approval Summary: Imetelstat for Selected Patients With Low- to Intermediate-1 Risk Myelodysplastic Syndromes With Transfusion-Dependent Anemia.” <em>The Oncologist</em> (2025). PMID: 41135032.</a></p><p><a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imetelstat-low-intermediate-1-risk-myelodysplastic-syndromes-transfusion-dependent">FDA. “FDA Approves Imetelstat for Low- to Intermediate-1-Risk Myelodysplastic Syndromes with Transfusion-Dependent Anemia.” June 2024.</a></p><p><a href="https://icer.org/wp-content/uploads/2024/08/MDS_Final-Report_For-Publication_08222024.pdf">ICER. “Evidence Report: Treatment for Anemia in Myelodysplastic Syndrome.” August 2024. </a></p><p><a href="https://icer.org/news-insights/press-releases/institute-for-clinical-and-economic-review-publishes-evidence-report-on-treatment-for-anemia-in-myelodysplastic-syndrome/">ICER. Press Release on Imetelstat Evidence Assessment. </a></p><p><a href="https://clinicaltrials.gov/study/NCT01217008">ClinicalTrials.gov. GRNOPC1 Phase I Trial. NCT01217008. </a></p><p><a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC4553145/">Myelodysplastic Syndrome Epidemiology. PMC4553145.</a></p><p><a href="https://ashpublications.org/blood/article/142/26/2247/498176/Diagnosis-and-classification-of-myelodysplastic">MDS Risk and AML Progression. Blood (2023). </a></p><p><strong>IV. CORPORATE FILINGS &amp; PRESENTATIONS</strong></p><p><a href="https://d18rn0p25nwr6d.cloudfront..."></a></p>]]>
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        <![CDATA[<p>Listen on <a href="https://open.spotify.com/episode/4COpXyTfI7jifq6da7wM52?si=EHI93INORPWlX8CabI6wcg">Spotify</a></p><p>Listen on <a href="https://podcasts.apple.com/us/podcast/episode-2-geron/id1873356046?i=1000755117965">Apple Podcasts</a></p><p>Listen on <a href="https://www.youtube.com/watch?v=ryeqeon5y4s">YouTube</a></p><p><strong>TABLE OF CONTENTS</strong></p><p>(00:00:00) - Introduction </p><p>(00:01:19) - Hayflick Limit </p><p>(00:08:30) - Michael West &amp; Founding of Geron </p><p>(00:15:16) - Early Science &amp; IP Strategy </p><p>(00:27:25) - Cloning the Telomerase Gene </p><p>(00:29:30) - Embryonic Stem Cells &amp; Political Context </p><p>(00:44:21) - Okarma, West’s Departure &amp; Corporate Turmoil </p><p>(01:05:08) - Spinal Cord Injury Trial </p><p>(01:30:45) - Pivot to Blood Cancer </p><p>(01:43:08) - Clinical &amp; Commercial Drama</p><p>(02:01:45) - Legacy &amp; Lessons</p><p><strong>CREDITS</strong></p><p>Co-hosted by Alex Kesin and Matthew Pech</p><p>Written, edited, and produced by Alex Kesin</p><p>Music: <a href="https://www.youtube.com/watch?v=4PoCA4taNyg">“Food”</a> by nerowski</p><p>* Special thanks to the team at <a href="https://www.nfx.com/">NFX</a> for the use of their recording studio.</p><p><strong>SOURCES</strong></p><p><strong><em>Last updated: March 2026</em></strong></p><p><strong>I. BOOKS</strong></p><p><a href="https://www.amazon.com/Merchants-Immortality-Pa-Stephen-Hall/dp/0618492216">Hall, Stephen S. <em>Merchants of Immortality: Chasing the Dream of Human Life Extension.</em> Houghton Mifflin, 2003.</a></p><p><a href="https://www.amazon.com/Inevitable-Collision-Inspiring-Research-Conservative-ebook/dp/B00NGRMSHC">Williams, Tory. <em>Inevitable Collision: The Inspiring Story That Brought Stem Cell Research to Conservative America.</em>Mary Ann Liebert, Inc., 2014.</a></p><p><strong>II. KEY SCIENTIFIC PUBLICATIONS</strong></p><p><a href="https://pubmed.ncbi.nlm.nih.gov/13905658/">Hayflick, L. &amp; Moorhead, P.S. “The serial cultivation of human diploid cell strains.” Experimental Cell Research 25 (1961): 585–621.</a></p><p><a href="https://pubmed.ncbi.nlm.nih.gov/7605428/">Kim, N.W. et al. “Specific association of human telomerase activity with immortal cells and cancer.” Science 266, no. 5193 (1994): 2011–2015.</a></p><p><a href="https://pubmed.ncbi.nlm.nih.gov/7544491/">Feng, J. et al. “The RNA component of human telomerase.” Science 269, no. 5228 (1995): 1236–1241.</a></p><p><a href="https://www.science.org/doi/10.1126/science.277.5328.955">Nakamura, T.M. et al. “Telomerase catalytic subunit homologs from fission yeast and human.” Science 277, no. 5328 (1997): 955–959.</a></p><p><a href="https://www.cell.com/cell/pdf/S0092-8674(00)80538-3.pdf">Meyerson, M. et al. “hEST2, the putative human telomerase catalytic subunit gene, is up-regulated in tumor cells and during immortalization.” Cell 90, no. 4 (1997): 785–795.</a></p><p><a href="https://www.science.org/doi/10.1126/science.279.5349.349">Bodnar, A.G. et al. “Extension of life-span by introduction of telomerase into normal human cells.” Science 279, no. 5349 (1998): 349–352.</a></p><p><a href="https://www.science.org/doi/abs/10.1126/science.282.5391.1145">Thomson, J.A. et al. “Embryonic stem cell lines derived from human blastocysts.” Science 282, no. 5391 (1998): 1145–1147.</a></p><p><a href="https://pubmed.ncbi.nlm.nih.gov/12873987/">Asai, A. et al. “A novel telomerase template antagonist (GRN163) as a potential anticancer agent.” Cancer Research 63, no. 14 (2003): 3931–3939. </a></p><p><a href="https://pubmed.ncbi.nlm.nih.gov/15940257/">Herbert, B-S et al. “Effect of the lipid modification of GRN163.” Nature: Oncogene 24 (2005): 5765–5772. </a></p><p><a href="https://www.nejm.org/doi/full/10.1056/NEJMoa1503479">Baerlochr, G. et al. “A pilot study of the telomerase inhibitor imetelstat for myelofibrosis.” New England Journal of Medicine 373 (2015): 908–919. </a></p><p><a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01724-5/abstract">Platzbecker, U. et al. “Imetelstat in patients with lower-risk myelodysplastic syndromes who have relapsed or are refractory to erythropoiesis-stimulating agents (IMerge).” The Lancet (2024).</a></p><p><a href="https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.70076">Lennox, A.L et al. “Imetelstat, a novel, first-in-class telomerase inhibitor: Mechanism of action, clinical, and translational science.” <em>Clinical and Translational Science</em> 17, no. 11 (2024).</a></p><p><a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC4250218/">Scott, C. &amp; Magnus, D. “Wrongful Termination: Lessons From the Geron Clinical Trial” Stem Cell Reports 3, no. 5 (2014): 721–723. </a></p><p><strong>III. REGULATORY &amp; CLINICAL</strong></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217779s000lbl.pdf">Prescribing Information (Label) U.S. Food and Drug Administration. “RYTELO (imetelstat) for injection: Highlights of Prescribing Information.” NDA 217779. June 2024. </a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217779Orig1s000ltr.pdf">NDA Approval Letter U.S. Food and Drug Administration. “NDA Approval Letter: RYTELO (imetelstat) for injection.” NDA 217779. June 6, 2024. </a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217779Orig1s000OtherR.pdf">Multi-Discipline Review &amp; Evaluation U.S. Food and Drug Administration. “NDA Multi-Disciplinary Review and Evaluation: RYTELO (imetelstat).” NDA 217779Orig1s000. 2024. </a></p><p><a href="https://www.fda.gov/media/176966/download">ODAC Briefing Document U.S. Food and Drug Administration. “FDA Briefing Document: Oncologic Drugs Advisory Committee Meeting, NDA 217779, Imetelstat.” March 14, 2024. </a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217779Orig1s000RiskR.pdf">REMS/Risk Assessment Review U.S. Food and Drug Administration. “Risk Assessment and Risk Mitigation Review: RYTELO (imetelstat).” NDA 217779Orig1s000. 2024. </a></p><p><a href="https://ascopubs.org/doi/abs/10.1200/JCO-25-01369">Kim, N. et al. “US Food and Drug Administration Approval Summary: Imetelstat for Selected Patients With Low- to Intermediate-1 Risk Myelodysplastic Syndromes With Transfusion-Dependent Anemia.” <em>The Oncologist</em> (2025). PMID: 41135032.</a></p><p><a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imetelstat-low-intermediate-1-risk-myelodysplastic-syndromes-transfusion-dependent">FDA. “FDA Approves Imetelstat for Low- to Intermediate-1-Risk Myelodysplastic Syndromes with Transfusion-Dependent Anemia.” June 2024.</a></p><p><a href="https://icer.org/wp-content/uploads/2024/08/MDS_Final-Report_For-Publication_08222024.pdf">ICER. “Evidence Report: Treatment for Anemia in Myelodysplastic Syndrome.” August 2024. </a></p><p><a href="https://icer.org/news-insights/press-releases/institute-for-clinical-and-economic-review-publishes-evidence-report-on-treatment-for-anemia-in-myelodysplastic-syndrome/">ICER. Press Release on Imetelstat Evidence Assessment. </a></p><p><a href="https://clinicaltrials.gov/study/NCT01217008">ClinicalTrials.gov. GRNOPC1 Phase I Trial. NCT01217008. </a></p><p><a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC4553145/">Myelodysplastic Syndrome Epidemiology. PMC4553145.</a></p><p><a href="https://ashpublications.org/blood/article/142/26/2247/498176/Diagnosis-and-classification-of-myelodysplastic">MDS Risk and AML Progression. Blood (2023). </a></p><p><strong>IV. CORPORATE FILINGS &amp; PRESENTATIONS</strong></p><p><a href="https://d18rn0p25nwr6d.cloudfront..."></a></p>]]>
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      <pubDate>Fri, 13 Mar 2026 14:06:18 -0100</pubDate>
      <author>Alex Kesin</author>
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      <itunes:duration>8526</itunes:duration>
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        <![CDATA[<p>Listen on <a href="https://open.spotify.com/episode/4COpXyTfI7jifq6da7wM52?si=EHI93INORPWlX8CabI6wcg">Spotify</a></p><p>Listen on <a href="https://podcasts.apple.com/us/podcast/episode-2-geron/id1873356046?i=1000755117965">Apple Podcasts</a></p><p>Listen on <a href="https://www.youtube.com/watch?v=ryeqeon5y4s">YouTube</a></p><p><strong>TABLE OF CONTENTS</strong></p><p>(00:00:00) - Introduction </p><p>(00:01:19) - Hayflick Limit </p><p>(00:08:30) - Michael West &amp; Founding of Geron </p><p>(00:15:16) - Early Science &amp; IP Strategy </p><p>(00:27:25) - Cloning the Telomerase Gene </p><p>(00:29:30) - Embryonic Stem Cells &amp; Political Context </p><p>(00:44:21) - Okarma, West’s Departure &amp; Corporate Turmoil </p><p>(01:05:08) - Spinal Cord Injury Trial </p><p>(01:30:45) - Pivot to Blood Cancer </p><p>(01:43:08) - Clinical &amp; Commercial Drama</p><p>(02:01:45) - Legacy &amp; Lessons</p><p><strong>CREDITS</strong></p><p>Co-hosted by Alex Kesin and Matthew Pech</p><p>Written, edited, and produced by Alex Kesin</p><p>Music: <a href="https://www.youtube.com/watch?v=4PoCA4taNyg">“Food”</a> by nerowski</p><p>* Special thanks to the team at <a href="https://www.nfx.com/">NFX</a> for the use of their recording studio.</p><p><strong>SOURCES</strong></p><p><strong><em>Last updated: March 2026</em></strong></p><p><strong>I. BOOKS</strong></p><p><a href="https://www.amazon.com/Merchants-Immortality-Pa-Stephen-Hall/dp/0618492216">Hall, Stephen S. <em>Merchants of Immortality: Chasing the Dream of Human Life Extension.</em> Houghton Mifflin, 2003.</a></p><p><a href="https://www.amazon.com/Inevitable-Collision-Inspiring-Research-Conservative-ebook/dp/B00NGRMSHC">Williams, Tory. <em>Inevitable Collision: The Inspiring Story That Brought Stem Cell Research to Conservative America.</em>Mary Ann Liebert, Inc., 2014.</a></p><p><strong>II. KEY SCIENTIFIC PUBLICATIONS</strong></p><p><a href="https://pubmed.ncbi.nlm.nih.gov/13905658/">Hayflick, L. &amp; Moorhead, P.S. “The serial cultivation of human diploid cell strains.” Experimental Cell Research 25 (1961): 585–621.</a></p><p><a href="https://pubmed.ncbi.nlm.nih.gov/7605428/">Kim, N.W. et al. “Specific association of human telomerase activity with immortal cells and cancer.” Science 266, no. 5193 (1994): 2011–2015.</a></p><p><a href="https://pubmed.ncbi.nlm.nih.gov/7544491/">Feng, J. et al. “The RNA component of human telomerase.” Science 269, no. 5228 (1995): 1236–1241.</a></p><p><a href="https://www.science.org/doi/10.1126/science.277.5328.955">Nakamura, T.M. et al. “Telomerase catalytic subunit homologs from fission yeast and human.” Science 277, no. 5328 (1997): 955–959.</a></p><p><a href="https://www.cell.com/cell/pdf/S0092-8674(00)80538-3.pdf">Meyerson, M. et al. “hEST2, the putative human telomerase catalytic subunit gene, is up-regulated in tumor cells and during immortalization.” Cell 90, no. 4 (1997): 785–795.</a></p><p><a href="https://www.science.org/doi/10.1126/science.279.5349.349">Bodnar, A.G. et al. “Extension of life-span by introduction of telomerase into normal human cells.” Science 279, no. 5349 (1998): 349–352.</a></p><p><a href="https://www.science.org/doi/abs/10.1126/science.282.5391.1145">Thomson, J.A. et al. “Embryonic stem cell lines derived from human blastocysts.” Science 282, no. 5391 (1998): 1145–1147.</a></p><p><a href="https://pubmed.ncbi.nlm.nih.gov/12873987/">Asai, A. et al. “A novel telomerase template antagonist (GRN163) as a potential anticancer agent.” Cancer Research 63, no. 14 (2003): 3931–3939. </a></p><p><a href="https://pubmed.ncbi.nlm.nih.gov/15940257/">Herbert, B-S et al. “Effect of the lipid modification of GRN163.” Nature: Oncogene 24 (2005): 5765–5772. </a></p><p><a href="https://www.nejm.org/doi/full/10.1056/NEJMoa1503479">Baerlochr, G. et al. “A pilot study of the telomerase inhibitor imetelstat for myelofibrosis.” New England Journal of Medicine 373 (2015): 908–919. </a></p><p><a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01724-5/abstract">Platzbecker, U. et al. “Imetelstat in patients with lower-risk myelodysplastic syndromes who have relapsed or are refractory to erythropoiesis-stimulating agents (IMerge).” The Lancet (2024).</a></p><p><a href="https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.70076">Lennox, A.L et al. “Imetelstat, a novel, first-in-class telomerase inhibitor: Mechanism of action, clinical, and translational science.” <em>Clinical and Translational Science</em> 17, no. 11 (2024).</a></p><p><a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC4250218/">Scott, C. &amp; Magnus, D. “Wrongful Termination: Lessons From the Geron Clinical Trial” Stem Cell Reports 3, no. 5 (2014): 721–723. </a></p><p><strong>III. REGULATORY &amp; CLINICAL</strong></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217779s000lbl.pdf">Prescribing Information (Label) U.S. Food and Drug Administration. “RYTELO (imetelstat) for injection: Highlights of Prescribing Information.” NDA 217779. June 2024. </a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217779Orig1s000ltr.pdf">NDA Approval Letter U.S. Food and Drug Administration. “NDA Approval Letter: RYTELO (imetelstat) for injection.” NDA 217779. June 6, 2024. </a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217779Orig1s000OtherR.pdf">Multi-Discipline Review &amp; Evaluation U.S. Food and Drug Administration. “NDA Multi-Disciplinary Review and Evaluation: RYTELO (imetelstat).” NDA 217779Orig1s000. 2024. </a></p><p><a href="https://www.fda.gov/media/176966/download">ODAC Briefing Document U.S. Food and Drug Administration. “FDA Briefing Document: Oncologic Drugs Advisory Committee Meeting, NDA 217779, Imetelstat.” March 14, 2024. </a></p><p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217779Orig1s000RiskR.pdf">REMS/Risk Assessment Review U.S. Food and Drug Administration. “Risk Assessment and Risk Mitigation Review: RYTELO (imetelstat).” NDA 217779Orig1s000. 2024. </a></p><p><a href="https://ascopubs.org/doi/abs/10.1200/JCO-25-01369">Kim, N. et al. “US Food and Drug Administration Approval Summary: Imetelstat for Selected Patients With Low- to Intermediate-1 Risk Myelodysplastic Syndromes With Transfusion-Dependent Anemia.” <em>The Oncologist</em> (2025). PMID: 41135032.</a></p><p><a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imetelstat-low-intermediate-1-risk-myelodysplastic-syndromes-transfusion-dependent">FDA. “FDA Approves Imetelstat for Low- to Intermediate-1-Risk Myelodysplastic Syndromes with Transfusion-Dependent Anemia.” June 2024.</a></p><p><a href="https://icer.org/wp-content/uploads/2024/08/MDS_Final-Report_For-Publication_08222024.pdf">ICER. “Evidence Report: Treatment for Anemia in Myelodysplastic Syndrome.” August 2024. </a></p><p><a href="https://icer.org/news-insights/press-releases/institute-for-clinical-and-economic-review-publishes-evidence-report-on-treatment-for-anemia-in-myelodysplastic-syndrome/">ICER. Press Release on Imetelstat Evidence Assessment. </a></p><p><a href="https://clinicaltrials.gov/study/NCT01217008">ClinicalTrials.gov. GRNOPC1 Phase I Trial. NCT01217008. </a></p><p><a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC4553145/">Myelodysplastic Syndrome Epidemiology. PMC4553145.</a></p><p><a href="https://ashpublications.org/blood/article/142/26/2247/498176/Diagnosis-and-classification-of-myelodysplastic">MDS Risk and AML Progression. Blood (2023). </a></p><p><strong>IV. CORPORATE FILINGS &amp; PRESENTATIONS</strong></p><p><a href="https://d18rn0p25nwr6d.cloudfront..."></a></p>]]>
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      <title>Episode #1: Amylin Pharmaceuticals</title>
      <itunes:episode>1</itunes:episode>
      <podcast:episode>1</podcast:episode>
      <itunes:title>Episode #1: Amylin Pharmaceuticals</itunes:title>
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      <link>https://share.transistor.fm/s/c7b84a3f</link>
      <description>
        <![CDATA[<p>Listen on <a href="https://open.spotify.com/show/66IeBvvuoDma0ysf8c4I8Z">Spotify</a></p><p>Listen on <a href="https://podcasts.apple.com/us/podcast/episode-1-amylin-pharmaceuticals/id1873356046?i=1000747377804">Apple Podcasts</a></p><p>Listen on <a href="https://www.youtube.com/watch?v=cddzPaXBzqg">YouTube</a></p><p><strong>TABLE OF CONTENTS</strong></p><p>(00:00:00) - Introduction</p><p>(00:04:40) - $50 of Dried Lizard Venom</p><p>(00:29:17) - Fax of Death</p><p>(00:43:04) - Sleeping Beauty Awakens</p><p>(00:52:07) - Carl Icahn Sends a Letter</p><p>(01:09:19) - Endgame</p><p>(01:13:40) - Postmortem &amp; Playbook</p><p><strong>CREDITS</strong></p><p>Co-hosted by Alex Kesin and Matthew Pech </p><p>Written, edited, and produced by Alex Kesin</p><p>Music: <a href="https://www.youtube.com/watch?v=4PoCA4taNyg">“Food”</a> by nerowski</p><p>* Special thanks to the team at <a href="https://www.nfx.com/">NFX</a> for the use of their recording studio.</p><p>SOURCES</p><p><strong><em>Last updated: January 2026</em></strong></p><p><strong>I. PRIMARY DOCUMENTS</strong></p><p><strong>FDA Regulatory Documents</strong></p><p><strong>Symlin (pramlintide acetate) - NDA 21-332</strong></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin%2520Injection_approv.PDF">Approval Letter &amp; Package (March 16, 2005)</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin%2520Injection_medr.PDF">Medical Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin%2520Injection_statr.PDF">Statistical Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin%2520Injection_biopharmr.PDF">Clinical Pharmacology &amp; Biopharmaceutics Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin%2520Injection_admincorres.PDF">Administrative Documents &amp; Correspondence</a></p><p><strong>Byetta (exenatide) - NDA 21-773</strong></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_Byetta_approv.PDF">Approval Letter &amp; Package (April 28, 2005)</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_Byetta_medr.PDF">Medical Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_Byetta_statr.PDF">Statistical Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_Byetta_biopharmr.PDF">Clinical Pharmacology &amp; Biopharmaceutics Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_Byetta_admincorres.PDF">Administrative Documents &amp; Correspondence</a></p><p><strong>Bydureon (exenatide ER) - NDA 22-200</strong></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000Approv.pdf">Approval Letter (January 27, 2012)</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000OtherActionLtrs.pdf">Other Action Letters (Complete Response)</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000SumRedt.pdf">Summary Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000Rems.pdf">REMS</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000Admincorresedt.pdf">Administrative Correspondence</a></p><p><strong>SEC Filings &amp; Financial Documents</strong></p><p>* <a href="https://www.sec.gov/Archives/edgar/data/881464/000110465906007417/a06-4671_1ex99d1.htm">Amylin 2005 Results Press Release (Ex-99.1, 8-K)</a></p><p>* <a href="https://www.sec.gov/Archives/edgar/data/881464/000110465908005085/a08-3824_1ex99d1.htm">Amylin 2007 Results Press Release (Ex-99.1)</a></p><p>* <a href="https://www.sec.gov/Archives/edgar/data/881464/000119312512072788/d260205d10k.htm">Amylin 2011 Form 10-K (Net Product Sales)</a></p><p>* <a href="https://www.sec.gov/divisions/corpfin/cf-noaction/2009/icahnassociates032709-sec14-incoming.pdf">Carl Icahn SEC Filing (Schedule 13D)</a></p><p><strong>Proxy Fight &amp; Legal Documents</strong></p><p>* <a href="https://www.fiercebiotech.com/biotech/letter-from-carl-icahn-to-amylin-pharmaceutical">Carl Icahn Letter to Amylin (April 15, 2009)</a></p><p>* <a href="https://www.fiercebiotech.com/biotech/amylin-letter-to-carl-icahn">Amylin Response to Icahn (April 20, 2009)</a></p><p>* <a href="https://cvn.com/proceedings/police-fund-v-bradbury-amylin-trial-2009-05-04">Police Fund v. Bradbury (Amylin) Trial (May 4, 2009)</a></p><p>* <a href="https://investor.lilly.com/static-files/51a2a9a3-6b73-4e44-9f48-c22133624708">Lilly Litigation Ruling (May 25, 2011)</a></p><p><strong>II. ORAL HISTORY &amp; INTERVIEWS</strong></p><p>* <a href="https://library.ucsd.edu/dc/object/bb2187116q/_1_1.pdf">Howard Greene Oral History (UCSD Library, October 8, 2008)</a><em> - Primary source for Hybritech founding, Ted Greene’s background, and early Amylin history</em></p><p><strong>III. NEWS &amp; TRADE PRESS</strong></p><p><strong>2000</strong></p><p>* <a href="https://www.cbsnews.com/news/the-rumsfeld-resume/">“The Rumsfeld Resume” - CBS News (December 28, 2000)</a><em> - Donald Rumsfeld’s board tenure at Amylin (1991-1996)</em></p><p>* <a href="https://www.forbes.com/forbes/2000/0724/6603205a.html">“Roller Coasting” - Forbes (July 24, 2000)</a><em> - Joe Cook narrative, J&amp;J partnership collapse</em></p><p><strong>2005</strong></p><p>* <a href="https://www.nytimes.com/2005/03/19/business/investing-for-a-profit-and-a-daughters-health.html">“Investing for a Profit and a Daughter’s Health” - NYT (March 19, 2005)</a><em> - Allen Andersson investment story, “tablecloth deal”</em></p><p><strong>2006</strong></p><p>* <a href="https://www.nytimes.com/2006/03/02/business/worldbusiness/02iht-drug.html">“Diabetics see hope (and weight loss) in new drug” - NYT (March 2, 2006)</a><em> - “Lizzie” nickname, patient testimonials</em></p><p>* <a href="https://www.nytimes.com/2006/06/22/business/22diabetes.html">“4 Diabetes Drugs Are Seen Raising Hope and Profit” - NYT (June 22, 2006)</a><em> - Manufacturing shortage, 400,000+ patients</em></p><p>* <a href="https://www.heritage.org/public-health/commentary/dont-kill-life-saving-drugs">“Don’t kill off life-saving drugs” - Heritage Foundation (August 15, 2006)</a><em> - Policy perspective on Byetta’s potential impact</em></p><p>* <a href="https://diatribe.org/diabetes-medications/byetta-craze-first-salvo-promising-new-line-drugs">“Byetta Craze Is First Salvo in Promising New Line of Drugs” - diaTribe</a><em> - ADA conference chaos, “one man cried”</em></p><p><strong>2007</strong></p><p>* <a href="https://www.diabetesincontrol.com/dr-john-engs-research-found-that-the-saliva-of-the-gila-monster-contains-a-hormone-that-treats-diabetes-better-than-any-other-medicine/">Dr. John Eng Profile - Diabetes In Control (September 18, 2007)</a><em> - Eng’s discovery story, patent struggles, Amylin vs. Lilly negotiations</em></p><p><strong>2008</strong></p><p>* <a href="https://www.biospace.com/xenome-ltd-names-b-ian-t-nisbet-phd-b-as-ceo">Xenome/Amylin Partnership - BioSpace (February 5, 2008)</a><em> - Venom peptide library partnership</em></p><p><strong>2009</strong></p><p>* <a href="https://www.sandiegouniontribune.com/2009/10/10/eastbourne-capital-sells-entire-stake-in-amylin/">Eastbourne Capital Sells Stake - San Diego Union-Tribune (October 10, 2009)</a><em> - End of Eastbourne activist campaign</em></p><p>* <a href="https://cardiovascularbusiness.com/topics/clinical/structural-heart-disease/survey-additional-diabetes-drugs-dpp-iv-inhibitors-needed">Survey: Additional Diabetes Dru...</a></p>]]>
      </description>
      <content:encoded>
        <![CDATA[<p>Listen on <a href="https://open.spotify.com/show/66IeBvvuoDma0ysf8c4I8Z">Spotify</a></p><p>Listen on <a href="https://podcasts.apple.com/us/podcast/episode-1-amylin-pharmaceuticals/id1873356046?i=1000747377804">Apple Podcasts</a></p><p>Listen on <a href="https://www.youtube.com/watch?v=cddzPaXBzqg">YouTube</a></p><p><strong>TABLE OF CONTENTS</strong></p><p>(00:00:00) - Introduction</p><p>(00:04:40) - $50 of Dried Lizard Venom</p><p>(00:29:17) - Fax of Death</p><p>(00:43:04) - Sleeping Beauty Awakens</p><p>(00:52:07) - Carl Icahn Sends a Letter</p><p>(01:09:19) - Endgame</p><p>(01:13:40) - Postmortem &amp; Playbook</p><p><strong>CREDITS</strong></p><p>Co-hosted by Alex Kesin and Matthew Pech </p><p>Written, edited, and produced by Alex Kesin</p><p>Music: <a href="https://www.youtube.com/watch?v=4PoCA4taNyg">“Food”</a> by nerowski</p><p>* Special thanks to the team at <a href="https://www.nfx.com/">NFX</a> for the use of their recording studio.</p><p>SOURCES</p><p><strong><em>Last updated: January 2026</em></strong></p><p><strong>I. PRIMARY DOCUMENTS</strong></p><p><strong>FDA Regulatory Documents</strong></p><p><strong>Symlin (pramlintide acetate) - NDA 21-332</strong></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin%2520Injection_approv.PDF">Approval Letter &amp; Package (March 16, 2005)</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin%2520Injection_medr.PDF">Medical Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin%2520Injection_statr.PDF">Statistical Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin%2520Injection_biopharmr.PDF">Clinical Pharmacology &amp; Biopharmaceutics Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin%2520Injection_admincorres.PDF">Administrative Documents &amp; Correspondence</a></p><p><strong>Byetta (exenatide) - NDA 21-773</strong></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_Byetta_approv.PDF">Approval Letter &amp; Package (April 28, 2005)</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_Byetta_medr.PDF">Medical Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_Byetta_statr.PDF">Statistical Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_Byetta_biopharmr.PDF">Clinical Pharmacology &amp; Biopharmaceutics Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_Byetta_admincorres.PDF">Administrative Documents &amp; Correspondence</a></p><p><strong>Bydureon (exenatide ER) - NDA 22-200</strong></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000Approv.pdf">Approval Letter (January 27, 2012)</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000OtherActionLtrs.pdf">Other Action Letters (Complete Response)</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000SumRedt.pdf">Summary Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000Rems.pdf">REMS</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000Admincorresedt.pdf">Administrative Correspondence</a></p><p><strong>SEC Filings &amp; Financial Documents</strong></p><p>* <a href="https://www.sec.gov/Archives/edgar/data/881464/000110465906007417/a06-4671_1ex99d1.htm">Amylin 2005 Results Press Release (Ex-99.1, 8-K)</a></p><p>* <a href="https://www.sec.gov/Archives/edgar/data/881464/000110465908005085/a08-3824_1ex99d1.htm">Amylin 2007 Results Press Release (Ex-99.1)</a></p><p>* <a href="https://www.sec.gov/Archives/edgar/data/881464/000119312512072788/d260205d10k.htm">Amylin 2011 Form 10-K (Net Product Sales)</a></p><p>* <a href="https://www.sec.gov/divisions/corpfin/cf-noaction/2009/icahnassociates032709-sec14-incoming.pdf">Carl Icahn SEC Filing (Schedule 13D)</a></p><p><strong>Proxy Fight &amp; Legal Documents</strong></p><p>* <a href="https://www.fiercebiotech.com/biotech/letter-from-carl-icahn-to-amylin-pharmaceutical">Carl Icahn Letter to Amylin (April 15, 2009)</a></p><p>* <a href="https://www.fiercebiotech.com/biotech/amylin-letter-to-carl-icahn">Amylin Response to Icahn (April 20, 2009)</a></p><p>* <a href="https://cvn.com/proceedings/police-fund-v-bradbury-amylin-trial-2009-05-04">Police Fund v. Bradbury (Amylin) Trial (May 4, 2009)</a></p><p>* <a href="https://investor.lilly.com/static-files/51a2a9a3-6b73-4e44-9f48-c22133624708">Lilly Litigation Ruling (May 25, 2011)</a></p><p><strong>II. ORAL HISTORY &amp; INTERVIEWS</strong></p><p>* <a href="https://library.ucsd.edu/dc/object/bb2187116q/_1_1.pdf">Howard Greene Oral History (UCSD Library, October 8, 2008)</a><em> - Primary source for Hybritech founding, Ted Greene’s background, and early Amylin history</em></p><p><strong>III. NEWS &amp; TRADE PRESS</strong></p><p><strong>2000</strong></p><p>* <a href="https://www.cbsnews.com/news/the-rumsfeld-resume/">“The Rumsfeld Resume” - CBS News (December 28, 2000)</a><em> - Donald Rumsfeld’s board tenure at Amylin (1991-1996)</em></p><p>* <a href="https://www.forbes.com/forbes/2000/0724/6603205a.html">“Roller Coasting” - Forbes (July 24, 2000)</a><em> - Joe Cook narrative, J&amp;J partnership collapse</em></p><p><strong>2005</strong></p><p>* <a href="https://www.nytimes.com/2005/03/19/business/investing-for-a-profit-and-a-daughters-health.html">“Investing for a Profit and a Daughter’s Health” - NYT (March 19, 2005)</a><em> - Allen Andersson investment story, “tablecloth deal”</em></p><p><strong>2006</strong></p><p>* <a href="https://www.nytimes.com/2006/03/02/business/worldbusiness/02iht-drug.html">“Diabetics see hope (and weight loss) in new drug” - NYT (March 2, 2006)</a><em> - “Lizzie” nickname, patient testimonials</em></p><p>* <a href="https://www.nytimes.com/2006/06/22/business/22diabetes.html">“4 Diabetes Drugs Are Seen Raising Hope and Profit” - NYT (June 22, 2006)</a><em> - Manufacturing shortage, 400,000+ patients</em></p><p>* <a href="https://www.heritage.org/public-health/commentary/dont-kill-life-saving-drugs">“Don’t kill off life-saving drugs” - Heritage Foundation (August 15, 2006)</a><em> - Policy perspective on Byetta’s potential impact</em></p><p>* <a href="https://diatribe.org/diabetes-medications/byetta-craze-first-salvo-promising-new-line-drugs">“Byetta Craze Is First Salvo in Promising New Line of Drugs” - diaTribe</a><em> - ADA conference chaos, “one man cried”</em></p><p><strong>2007</strong></p><p>* <a href="https://www.diabetesincontrol.com/dr-john-engs-research-found-that-the-saliva-of-the-gila-monster-contains-a-hormone-that-treats-diabetes-better-than-any-other-medicine/">Dr. John Eng Profile - Diabetes In Control (September 18, 2007)</a><em> - Eng’s discovery story, patent struggles, Amylin vs. Lilly negotiations</em></p><p><strong>2008</strong></p><p>* <a href="https://www.biospace.com/xenome-ltd-names-b-ian-t-nisbet-phd-b-as-ceo">Xenome/Amylin Partnership - BioSpace (February 5, 2008)</a><em> - Venom peptide library partnership</em></p><p><strong>2009</strong></p><p>* <a href="https://www.sandiegouniontribune.com/2009/10/10/eastbourne-capital-sells-entire-stake-in-amylin/">Eastbourne Capital Sells Stake - San Diego Union-Tribune (October 10, 2009)</a><em> - End of Eastbourne activist campaign</em></p><p>* <a href="https://cardiovascularbusiness.com/topics/clinical/structural-heart-disease/survey-additional-diabetes-drugs-dpp-iv-inhibitors-needed">Survey: Additional Diabetes Dru...</a></p>]]>
      </content:encoded>
      <pubDate>Fri, 30 Jan 2026 15:33:19 -0100</pubDate>
      <author>Alex Kesin</author>
      <enclosure url="https://op3.dev/e/media.transistor.fm/c7b84a3f/85efb6ca.mp3" length="76647807" type="audio/mpeg"/>
      <itunes:author>Alex Kesin</itunes:author>
      <itunes:image href="https://img.transistorcdn.com/tAVdHiR1u98yp1A-1wyxsv3D9UCT0LFjWT694ExXgxo/rs:fill:0:0:1/w:1400/h:1400/q:60/mb:500000/aHR0cHM6Ly9pbWct/dXBsb2FkLXByb2R1/Y3Rpb24udHJhbnNp/c3Rvci5mbS85NzI5/OTA3NWNjZGNkN2Fk/YWM5NjE3ZTVjODc2/YmI2OC5qcGc.jpg"/>
      <itunes:duration>6388</itunes:duration>
      <itunes:summary>
        <![CDATA[<p>Listen on <a href="https://open.spotify.com/show/66IeBvvuoDma0ysf8c4I8Z">Spotify</a></p><p>Listen on <a href="https://podcasts.apple.com/us/podcast/episode-1-amylin-pharmaceuticals/id1873356046?i=1000747377804">Apple Podcasts</a></p><p>Listen on <a href="https://www.youtube.com/watch?v=cddzPaXBzqg">YouTube</a></p><p><strong>TABLE OF CONTENTS</strong></p><p>(00:00:00) - Introduction</p><p>(00:04:40) - $50 of Dried Lizard Venom</p><p>(00:29:17) - Fax of Death</p><p>(00:43:04) - Sleeping Beauty Awakens</p><p>(00:52:07) - Carl Icahn Sends a Letter</p><p>(01:09:19) - Endgame</p><p>(01:13:40) - Postmortem &amp; Playbook</p><p><strong>CREDITS</strong></p><p>Co-hosted by Alex Kesin and Matthew Pech </p><p>Written, edited, and produced by Alex Kesin</p><p>Music: <a href="https://www.youtube.com/watch?v=4PoCA4taNyg">“Food”</a> by nerowski</p><p>* Special thanks to the team at <a href="https://www.nfx.com/">NFX</a> for the use of their recording studio.</p><p>SOURCES</p><p><strong><em>Last updated: January 2026</em></strong></p><p><strong>I. PRIMARY DOCUMENTS</strong></p><p><strong>FDA Regulatory Documents</strong></p><p><strong>Symlin (pramlintide acetate) - NDA 21-332</strong></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin%2520Injection_approv.PDF">Approval Letter &amp; Package (March 16, 2005)</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin%2520Injection_medr.PDF">Medical Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin%2520Injection_statr.PDF">Statistical Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin%2520Injection_biopharmr.PDF">Clinical Pharmacology &amp; Biopharmaceutics Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin%2520Injection_admincorres.PDF">Administrative Documents &amp; Correspondence</a></p><p><strong>Byetta (exenatide) - NDA 21-773</strong></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_Byetta_approv.PDF">Approval Letter &amp; Package (April 28, 2005)</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_Byetta_medr.PDF">Medical Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_Byetta_statr.PDF">Statistical Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_Byetta_biopharmr.PDF">Clinical Pharmacology &amp; Biopharmaceutics Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_Byetta_admincorres.PDF">Administrative Documents &amp; Correspondence</a></p><p><strong>Bydureon (exenatide ER) - NDA 22-200</strong></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000Approv.pdf">Approval Letter (January 27, 2012)</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000OtherActionLtrs.pdf">Other Action Letters (Complete Response)</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000SumRedt.pdf">Summary Review</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000Rems.pdf">REMS</a></p><p>* <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000Admincorresedt.pdf">Administrative Correspondence</a></p><p><strong>SEC Filings &amp; Financial Documents</strong></p><p>* <a href="https://www.sec.gov/Archives/edgar/data/881464/000110465906007417/a06-4671_1ex99d1.htm">Amylin 2005 Results Press Release (Ex-99.1, 8-K)</a></p><p>* <a href="https://www.sec.gov/Archives/edgar/data/881464/000110465908005085/a08-3824_1ex99d1.htm">Amylin 2007 Results Press Release (Ex-99.1)</a></p><p>* <a href="https://www.sec.gov/Archives/edgar/data/881464/000119312512072788/d260205d10k.htm">Amylin 2011 Form 10-K (Net Product Sales)</a></p><p>* <a href="https://www.sec.gov/divisions/corpfin/cf-noaction/2009/icahnassociates032709-sec14-incoming.pdf">Carl Icahn SEC Filing (Schedule 13D)</a></p><p><strong>Proxy Fight &amp; Legal Documents</strong></p><p>* <a href="https://www.fiercebiotech.com/biotech/letter-from-carl-icahn-to-amylin-pharmaceutical">Carl Icahn Letter to Amylin (April 15, 2009)</a></p><p>* <a href="https://www.fiercebiotech.com/biotech/amylin-letter-to-carl-icahn">Amylin Response to Icahn (April 20, 2009)</a></p><p>* <a href="https://cvn.com/proceedings/police-fund-v-bradbury-amylin-trial-2009-05-04">Police Fund v. Bradbury (Amylin) Trial (May 4, 2009)</a></p><p>* <a href="https://investor.lilly.com/static-files/51a2a9a3-6b73-4e44-9f48-c22133624708">Lilly Litigation Ruling (May 25, 2011)</a></p><p><strong>II. ORAL HISTORY &amp; INTERVIEWS</strong></p><p>* <a href="https://library.ucsd.edu/dc/object/bb2187116q/_1_1.pdf">Howard Greene Oral History (UCSD Library, October 8, 2008)</a><em> - Primary source for Hybritech founding, Ted Greene’s background, and early Amylin history</em></p><p><strong>III. NEWS &amp; TRADE PRESS</strong></p><p><strong>2000</strong></p><p>* <a href="https://www.cbsnews.com/news/the-rumsfeld-resume/">“The Rumsfeld Resume” - CBS News (December 28, 2000)</a><em> - Donald Rumsfeld’s board tenure at Amylin (1991-1996)</em></p><p>* <a href="https://www.forbes.com/forbes/2000/0724/6603205a.html">“Roller Coasting” - Forbes (July 24, 2000)</a><em> - Joe Cook narrative, J&amp;J partnership collapse</em></p><p><strong>2005</strong></p><p>* <a href="https://www.nytimes.com/2005/03/19/business/investing-for-a-profit-and-a-daughters-health.html">“Investing for a Profit and a Daughter’s Health” - NYT (March 19, 2005)</a><em> - Allen Andersson investment story, “tablecloth deal”</em></p><p><strong>2006</strong></p><p>* <a href="https://www.nytimes.com/2006/03/02/business/worldbusiness/02iht-drug.html">“Diabetics see hope (and weight loss) in new drug” - NYT (March 2, 2006)</a><em> - “Lizzie” nickname, patient testimonials</em></p><p>* <a href="https://www.nytimes.com/2006/06/22/business/22diabetes.html">“4 Diabetes Drugs Are Seen Raising Hope and Profit” - NYT (June 22, 2006)</a><em> - Manufacturing shortage, 400,000+ patients</em></p><p>* <a href="https://www.heritage.org/public-health/commentary/dont-kill-life-saving-drugs">“Don’t kill off life-saving drugs” - Heritage Foundation (August 15, 2006)</a><em> - Policy perspective on Byetta’s potential impact</em></p><p>* <a href="https://diatribe.org/diabetes-medications/byetta-craze-first-salvo-promising-new-line-drugs">“Byetta Craze Is First Salvo in Promising New Line of Drugs” - diaTribe</a><em> - ADA conference chaos, “one man cried”</em></p><p><strong>2007</strong></p><p>* <a href="https://www.diabetesincontrol.com/dr-john-engs-research-found-that-the-saliva-of-the-gila-monster-contains-a-hormone-that-treats-diabetes-better-than-any-other-medicine/">Dr. John Eng Profile - Diabetes In Control (September 18, 2007)</a><em> - Eng’s discovery story, patent struggles, Amylin vs. Lilly negotiations</em></p><p><strong>2008</strong></p><p>* <a href="https://www.biospace.com/xenome-ltd-names-b-ian-t-nisbet-phd-b-as-ceo">Xenome/Amylin Partnership - BioSpace (February 5, 2008)</a><em> - Venom peptide library partnership</em></p><p><strong>2009</strong></p><p>* <a href="https://www.sandiegouniontribune.com/2009/10/10/eastbourne-capital-sells-entire-stake-in-amylin/">Eastbourne Capital Sells Stake - San Diego Union-Tribune (October 10, 2009)</a><em> - End of Eastbourne activist campaign</em></p><p>* <a href="https://cardiovascularbusiness.com/topics/clinical/structural-heart-disease/survey-additional-diabetes-drugs-dpp-iv-inhibitors-needed">Survey: Additional Diabetes Dru...</a></p>]]>
      </itunes:summary>
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      <itunes:explicit>No</itunes:explicit>
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