Replies to post #502081 on Anavex Life Sciences Corp (AVXL)

[La Flaca]

WRONG - the practice is to rely on the most recent FDA draft guidances. You would be correct if the existing guidance for this particular disease were a FINAL guidance. But it was a draft guidance.

[ohsaycanyousee82]

The US Supreme Court is repeatedly proving your accusations to be nonsense.

[sab63090]

boi
I just wish you had more confidence in Dr. Makary....

I like the way he thinks about the problems the old FDA had, hope he is a positive figure and gets recognition for transparency

[Hoskuld]

I don't understand how EMA could require FDA to do...anything?

[Hoskuld]

OK, well we are not going to agree. But, the FDA is more than capable of (ie, in no way prohibited from) approving blarcasemine for AD, should they ever actually submit an NDA.

[rayovac812]

All someone needs to do is find a case where draft guidence was used, over-riding final draft guidance. If this can be found, then it would be procedural, and satisfactorily demonstrate that draft guidance is the rule.