TD Cowen Insights

TD Securities, TD Cowen

On each episode of "TD Cowen Insights", members of our firm host leading thinkers to share insights and ideas shaping the world economy. Join us, as we converse with the top minds who are influencing our global sectors. Disclosures: https://go.td.com/PodcastDisclosure

  1. Aug 11

    Navigating The FDA Playbook For Psychedelic Therapies

    Recorded on 07/17/26 TD Cowen senior analyst Ritu Baral hosts Michael McCaughan, founder of Prevision Policy, a leading provider of regulatory and reimbursement policy analysis for the biopharma industry. Discussion focused on the evolving regulatory landscape for psychedelic treatments. McCaughan views FDA as already receptive to psychedelics from the bottom up, with the recent executive order on accelerating psychedelic development and approval adding clear new top-down support. He does not believe the updated 2026 FDA industry guidance meaningfully changes the approvability bar for psychedelic sponsors, especially those with NDAs in progress. He views the recommendation for 12-month blinded follow-up as unlikely to be an approvability issue for these near term, and even Ph3 programs, although it could influence label language, durability claims, and claims on repeat dosing. On safety, he expects FDA to focus on if benefit outweighs key risks, including suicidality, abuse potential, and class-specific concerns such as cardiovascular or valvulopathy signals. He also expects a REMS framework anchored by in-office administration and misuse prevention, likely informed by Spravato but tailored to the psychedelic treatment model. Importantly, he believes FDA and DEA are likely to work together to minimize the gap between approval and rescheduling, though process and bureaucracy remain key timing variables. https://go.td.com/PodcastDisclosure Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

  2. Jul 14

    Inside A Non-Profit/Academic Interventional Psychiatry Clinic: Preparing For The Next Wave Of Psychedelic Treatments

    Recorded 07/07/26 Senior analyst Ritu Baral hosts Dr. Scott Aaronson, Chief Science Officer for Advanced Diagnostics and Therapeutics at Sheppard Pratt Health System, to discuss operations at a nonprofit/academic interventional psychiatry clinic and how the model may evolve as new psychedelic treatment modalities, including psilocybin-based therapies, move closer to potential approval. Dr. Aaronson underscores the substantial unmet need in TRD, noting that these are highly ill patients with meaningful morbidity and mortality risk, making durability and the ability to re-dose clinically important. He notes that current interventional options offered at his clinic, including ECT and TMS, remain constrained by reimbursement, staffing, and site-of-care economics, with hospital-based settings generally better positioned than private practices to absorb monitoring and overhead costs. Looking ahead, he sees clinical utility for psilocybin-based therapies such as COMP360, while highlighting key implementation questions around reimbursement feasibility, supervised dosing infrastructure, preparation/integration requirements, and rigorous patient screening for psychosis risk as access expands. https://go.td.com/PodcastDisclosure Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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On each episode of "TD Cowen Insights", members of our firm host leading thinkers to share insights and ideas shaping the world economy. Join us, as we converse with the top minds who are influencing our global sectors. Disclosures: https://go.td.com/PodcastDisclosure

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