Replies to post #492467 on Anavex Life Sciences Corp (AVXL)

[Bourbon_on_my_cornflakes]

I read an FDA response recently for a company who drug had completed P2 and was designing P3.

I was struck by the relative lack of technical questions. It was more along the lines of clarifying the P3. The type of thoughtful requests/questions that a good nonscientific lawyer would write, not a science PhD.

While it may be different when filing for approval or different with the EMA, I wonder if by now, AVXL knows from the questions asked, if "we got this".

In other words, if they are not fundamentally questioning the test results or endpoints, but just asking for more details or what they might follow up with in a P4 or questions about manufacturing and marketing, Softball questions in other words, to show they did their job, but aren't really questioning the coming approval.

That might play into the new PR effort if the questions are of the latter sort, and easily answered by AVXL

[rx7171]

What I find curious is this marketing effort will be seen by Americans yet the upcoming marketing approval is in Europe.
Until a NDA is submitted to the FDA getting folk here all excited seems premature.

Unless Missling is attempting to create some buzz to help share price, which is ok with me.