Anavex Life Sciences Corp (AVXL)

[Bourbon_on_my_cornflakes]

Agree:

If my understanding is correct, new information will not be brought in because the administrative record has been closed. What you are getting instead is a second opinion on the existing material, and not a new version of the MAA. This is the way decision making bodies work in an appeal. Reviewers don't retry the case, they instead review the performance of the initial fact finder.

Thus it is unlikely we get approved in December. At that point, AVXL can ask for a second take, if I understand correctly, with new rappateurs. That is the point where all the additional evidence can be introduced, and apparently a post-hoc subgroup analysis got lequembi over the goal line. That is what I would hope the ABCLEAR data and the brain volume data do for 273.

This would fit into my hypothesis about bureaucratic CYA. The say no first, and then AVXL can bring in all the subsequent data, at which point CYA achieved and hopefully we get a yes. That is the rational CYA path for the bureaucrat.