Approved

Listen on SpotifyListen on Apple PodcastsListen on YouTubeTABLE OF CONTENTS(00:00:00) - Introduction(00:04:40) - $50 of Dried Lizard Venom(00:29:17) - Fax of Death(00:43:04) - Sleeping Beauty Awakens(00:52:07) - Carl Icahn Sends a Letter(01:09:19) - Endgame(01:13:40) - Postmortem & PlaybookCREDITSCo-hosted by Alex Kesin and Matthew Pech Written, edited, and produced by Alex KesinMusic: “Food” by nerowski* Special thanks to the team at NFX for the use of their recording studio.SOURCESLast updated: January 2026I. PRIMARY DOCUMENTSFDA Regulatory DocumentsSymlin (pramlintide acetate) - NDA 21-332* Approval Letter & Package (March 16, 2005)* Medical Review* Statistical Review* Clinical Pharmacology & Biopharmaceutics Review* Administrative Documents & CorrespondenceByetta (exenatide) - NDA 21-773* Approval Letter & Package (April 28, 2005)* Medical Review* Statistical Review* Clinical Pharmacology & Biopharmaceutics Review* Administrative Documents & CorrespondenceBydureon (exenatide ER) - NDA 22-200* Approval Letter (January 27, 2012)* Other Action Letters (Complete Response)* Summary Review* REMS* Administrative CorrespondenceSEC Filings & Financial Documents* Amylin 2005 Results Press Release (Ex-99.1, 8-K)* Amylin 2007 Results Press Release (Ex-99.1)* Amylin 2011 Form 10-K (Net Product Sales)* Carl Icahn SEC Filing (Schedule 13D)Proxy Fight & Legal Documents* Carl Icahn Letter to Amylin (April 15, 2009)* Amylin Response to Icahn (April 20, 2009)* Police Fund v. Bradbury (Amylin) Trial (May 4, 2009)* Lilly Litigation Ruling (May 25, 2011)II. ORAL HISTORY & INTERVIEWS* Howard Greene Oral History (UCSD Library, October 8, 2008) - Primary source for Hybritech founding, Ted Greene’s background, and early Amylin historyIII. NEWS & TRADE PRESS2000* “The Rumsfeld Resume” - CBS News (December 28, 2000) - Donald Rumsfeld’s board tenure at Amylin (1991-1996)* “Roller Coasting” - Forbes (July 24, 2000) - Joe Cook narrative, J&J partnership collapse2005* “Investing for a Profit and a Daughter’s Health” - NYT (March 19, 2005) - Allen Andersson investment story, “tablecloth deal”2006* “Diabetics see hope (and weight loss) in new drug” - NYT (March 2, 2006) - “Lizzie” nickname, patient testimonials* “4 Diabetes Drugs Are Seen Raising Hope and Profit” - NYT (June 22, 2006) - Manufacturing shortage, 400,000+ patients* “Don’t kill off life-saving drugs” - Heritage Foundation (August 15, 2006) - Policy perspective on Byetta’s potential impact* “Byetta Craze Is First Salvo in Promising New Line of Drugs” - diaTribe - ADA conference chaos, “one man cried”2007* Dr. John Eng Profile - Diabetes In Control (September 18, 2007) - Eng’s discovery story, patent struggles, Amylin vs. Lilly negotiations2008* Xenome/Amylin Partnership - BioSpace (February 5, 2008) - Venom peptide library partnership2009* Eastbourne Capital Sells Stake - San Diego Union-Tribune (October 10, 2009) - End of Eastbourne activist campaign* Survey: Additional Diabetes Drugs Needed - Cardiovascular Business (December 21, 2009) - Market research on GLP-1 adoption2012* “FDA review accuses Amylin of withholding data” - FierceBiotech (June 26, 2012) - Bydureon approval controversyIV. ACADEMIC & SCIENTIFIC SOURCES* “Structural insights into multiplexed pharmacological actions of tirzepatide...” - Nature Communications (February 25, 2022) - Tirzepatide structure, exenatide C-terminus connection* “Structural and dynamic features of cagrilintide binding...” - Nature Communications (April 10, 2025) - Cagrilintide/pramlintide structural relationship* “If You Poison Us Do We Not Die?” - BYU Law Review (May 1, 2010) - Legal analysis of poison put provisions* “How GLP-1 Receptor Agonists Evolved from Diabetes to Weight Loss Treatments” - Historical overview of GLP-1 developmentV. HARVARD BUSINESS SCHOOL CASES* “Amylin Pharmaceuticals: Diabetes and Beyond” (December 9, 2008) - Authors: Richard G. Hamermesh, Rachel Gordon* “Amylin Pharmaceuticals: Diabetes and Beyond” (November 2, 2012 revision) - Authors: Richard G. Hamermesh, Carin-Isabel KnoopVI. CORPORATE DOCUMENTS & PRESENTATIONSAmylin investor presentations from corporate IR archives. Specific slides referenced in the script are noted below.Investor Presentations (Full Decks)* 2006 R&D Day Presentation (PDF) - Phybrids platform, GIP mimetic program (slides 43, 46, 58-59)* 2007 R&D Day Presentation (PDF) - Market sizing, obesity portfolio positioning (slides 14, 28, 29, 78)* 2007 J.P. Morgan Healthcare Conference (PDF) - Symlin Pen timeline (slide 25)* 2007 Lehman Brothers Healthcare Conference (PDF) - Investor overview and pipeline updateIndividual Slide Presentations (HTML Archives)* Early Corporate Presentation (WFVK) - Early-era company overview* 2003 Headquarters Presentation - January 2003 corporate update* ADA IR Presentation - American Diabetes Association investor materialsVII. ADDITIONAL REFERENCES* Encyclopedia.com: Amylin Pharmaceuticals, Inc.* Miami Serpentarium Laboratories (Gila monster venom source)* Dan Bradbury (former Amylin CEO) - Vivani Board Profile - Now developing exenatide implant for weight loss* Full-year 2008 results - FierceBiotechVIII. PRIMARY SOURCE FIGURESIX. ANALYSIS FIGURES This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.approved.fm