Anavex Life Sciences Corp (AVXL)

[Steady_T]

I suspect a peer reviewed paper is not cause for a meeting. Perhaps a supporting document in concert with other docs to discuss a specific agenda item.

Meetings with the FDA are not casual affairs. The documents and information have to be provided to the FDA well in advance of the meeting to allow the FDA people involved to review and come to the meeting informed with their own thoughts and questions. The guidance and recommendations that result from a meeting are considered to be the official position of the FDA. As I understand it those are not legally binding but one challenges the bureaucracy at one's own risk.

As I see it a peer reviewed paper would be included in an NDA as a supporting document.

Doc can weigh in on this. I see a peer reviewed paper as legitimizing the company's statements about a trial outcome. A more in depth review and analysis of a trial and the conclusion derived from the trial. It should have sufficient information to allow knowledgeable people to arrive at their own conclusions concerning the trial methodology and results.

A positive peer reviewed paper will be taken seriously by the biotech investing community far more than the company's pronouncements about a trail and the results.