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FDA Begins Public Release of Complete Response Letters for Drug Applications

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Source: Psychedelic Alpha
FDA Begins Public Release of Complete Response Letters for Drug Applications
Photo: Psychedelic Alpha
TL;DR Summary

The FDA released a complete response letter to Lykos Therapeutics' MDMA for PTSD application, citing issues like unreported adverse events, lack of durability data, and high prior MDMA use among participants, and recommended conducting new clinical trials with specific focus areas.

Topics:business#clinical-trials#crl#fda#health#lykos-therapeutics#mdma
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  1. BREAKING: FDA Publishes Lykos Therapeutics’ MDMA Complete Response Letter (CRL)  Psychedelic Alpha
  2. FDA moves to publish drug rejection letters in real time, releases new batch including Replimune's high-profile snub  Fierce Biotech
  3. In major shift, FDA to start releasing rejection letters shortly after they’re issued  statnews.com
  4. In a first, FDA publishes complete response letters for ongoing drug applications  Endpoints News
  5. MAPS Statement on FDA’s Public Release of Complete Response Letter for MDMA-assisted Therapy  GlobeNewswire

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