InvestorsHub Logo

georgejjl

08/26/23 8:01 PM

#428592 RE: Investor2014 #428590

A Phase 4 confirmatory trial is a condition for receiving accelerated approval to start selling the drug (blarcamesine)

Drugs approved under the FDA Accelerated Approval Program still need to be tested in clinical trials using endpoints that demonstrate clinical benefit, and those trials are known as phase 4 confirmatory trials.



https://en.wikipedia.org/wiki/Accelerated_approval_(FDA)

STOP posting FUD.

GOD bless,

Hoskuld

08/26/23 8:31 PM

#428596 RE: Investor2014 #428590

Rationalism versus empiricism is an old cycle. I prefer empiricism and so does the FDA and EMEA. You can embrace Zeno's Paradox but Anavex will simply bring 2-73 to market for Rett and AD while you ponder its impossibliity.