...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Phase 3 BETonMACE Trial is Now Completed. Cognition and CKD Sub-Study Results to be Announced Soon.

Free
Message: Short interest uptick

Re your second para oldtimer, I think it’s unlikely the FDA meets with all companies post-trial. After all, what would be the point if, as often is the case, a trial is unequivocally negative? In the absence of any safety issue, I would imagine a post-trial meeting is held only when:

1. The endpoint results have raised the possibility of marketing approval for one or more conditions; 

or

2. The results for an important endpoint just missed statistical significance and the company wants to reach agreement with the FDA on the way forward.

Share
New Message
Please login to post a reply