Replies to post #403132 on Anavex Life Sciences Corp (AVXL)

[LakeshoreLeo1953]

“RSBQ-AUC had been a pre-specified analysis from the beginning of the AVATAR study. The primary endpoint change was implemented before the database lock in the study, simultaneously also changing the study from a Phase II to a Phase III study incorporating guidance from the FDA. However, the administrative update on the clinicaltrials.gov website was not made on a timely basis by the CRO, leaving the inaccurate impression of a late change — which was factually not the case. We advise that Clincialtrials.gov website should not be relied upon — only direct communication from the company.”

Attribution Andrew Barwicki

So You would have to ask....What FDA guidance? draft? document? conversation?
phone inquiry to FDA PR Dept? Just wondering as he was authorized by someone to issue that statement.

Really not concerned with the value or applicability of the methodology as it is not my field.
Merely asking for clarification of the person, instrument, specifics for the Guidance cited.

Seems a simple enough question that to some has not been adequately addressed.
IF you are aware of such clarification it may actually be a beneficial submission for review on this MB.

Any snarky response?