Anavex Life Sciences Corp (AVXL)

[Steady_T]

You might want to spend a little time with Google before you make your posts about what the FDA does and doesn't do.

According to a 2014 JAMA study, between 2005 and 2012, FDA approved 188 novel therapeutic agents for 206 indications, and 74 indications (36.8%) were approved on the basis of a single pivotal trial.

Most recently, IQVIA released a report finding that 25 of 59 (42%) novel drugs approved in 2018 were approved on the basis of only one trial. And one out of eight approvals relied only on Phase 1 or 2 trials, with no Phase 3 trials. But as in previous years, a large portion of the drugs relying on only one trial were new orphan and cancer drugs.

Generally, only drugs that have successfully navigated the first three phases can be considered for FDA approval, although regulators sometimes approve new drugs without a phase III trial. (Of the 59 drugs approved in 2018, 7 did not undergo phase III trials before approval.)19 I

https://tinyurl.com/y2kpxve8