Replies to post #508077 on Anavex Life Sciences Corp (AVXL)

[hnbadger1]

Boi, are saying that Jesse is incorrect?

“ The company is almost certainly going to appeal as soon as possible (in Dec) to try again with approval. The difference is that with appeal, they CAN use all the aforementioned data which insurmountably improves the strength of the filing, with all that information now able to be officially considered by the CHMP. This process is 15 days for the company to appeal, 60 days to give new data, 60 days for CHMP to give new opinion.”

[frrol]

Court procedures don't apply here necessarily, of course, and Anavex will be informed of what is allowed and what is not. Let's see what the company has to say.

[Kentucky123]

Thanks. All they needed for approval was 16. They did not have that many. They can not submit new information. The OE did not persuade enough to approve. It is a flop. Would need a new trial. Take many years.

[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.

[rx7171]

With two new rapporteurs hopefully a fresh perspective on the.value of the data already submitted.