Lykos Plots FDA Appeal: Reeling from CRL and Journal Article Retractions, MDMA Developer Hopes to Change Your Mind

While I, like many others, had expected Lykos to receive a Complete Response Letter (CRL) from the FDA last week, I was not expecting the agency to request fresh Phase 3 data. While we have no eyes on the letter, the issues with the package must have been significant for the FDA to impose such a requirement. There’s much to be said, but here I focus on three threads that I have been pulling on…

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