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Re: sts66 post# 210072

Tuesday, 08/20/2019 4:18:25 PM

Tuesday, August 20, 2019 4:18:25 PM

Post# of 428330

Curious as to who you think was the outside influencer in this case?



Department of Defense / anti-opioid furor.

Adcom for Dsuvia and Oli were held on the same day, IIRC. If you listen to both (I did), the demeanor is very different for both.

Unfortunately, I knew it was going to be a close call... on stocktwits I opined that the final vote would be 8-7 recommending to approve, with a chance of a 7-8 vote recommending against. Ultimately it was 7-8. Part of the issue was the terrible state of the FDA briefing docs. They issued an errata hours before the ad-com.

Anyway, the request in the CRL was a huge one... it will delay approval by a year, but Trevena will survive and hopefully get approval here in the next 6 months.
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