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| Hans-Günter Meyer-Thompson | Amphetamine

Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD

Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD

U.S. Food and Drug Administration requests additional Phase 3 study

Issues raised in CRL echo those discussed in FDA Advisory Committee hearing

The Company intends to pursue all available regulatory pathways to expeditiously bring a potential new treatment to the 13 million Americans who live with PTSD, a condition that has not had new treatments available for nearly 25 years1,2 

(Lykos Therapeutics, USA, 09.08.2024)

https://news.lykospbc.com/2024-08-09-Lykos-Therapeutics-Announces-Complete-Response-Letter-for-Midomafetamine-Capsules-for-PTSD