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Re: georgejjl post# 452881

Tuesday, 02/27/2024 9:44:36 PM

Tuesday, February 27, 2024 9:44:36 PM

Post# of 458362
Do you know how well our data compares with the data being cited here:

https://finance.yahoo.com/news/minerva-neurosciences-receives-complete-response-130000303.html

They got the dreaded CRL.

For a Phase 2 to gain approval it must have been done with pivotal quality material, do you know that to be the case. If it is, it could be referred to as a Registrational Phase 2.

Personally I'd like to see the FDA do more conditional approvals, either requiring a confirming trial, or for all receiving the drug reporting results in a Phase 4, perhaps even both until they're satisfied with a benefit. All to often tiny companies can't afford the further testing the FDA requires and good drugs are either abandoned, or sold to a BP dirt cheaply.

Gary
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