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Tuesday, 01/03/2023 4:36:52 PM

Tuesday, January 03, 2023 4:36:52 PM

Post# of 462021
A couple of things. Didn't Missling state that he was going forward with all regulatory agencies before the end of the year and look for accelerated approval? I thought he stated that on the Monday call after the CTAD meeting. Second, I think that the FDA screw up with Biogen only helps Anavex.

In this article https://endpts.com/congressional-inquiry-into-highly-atypical-fda-biogen-ties-ends-with-damning-report-no-repercussions/ the FDA states the following: FDA reviewers and the agency’s report noted that these regular meetings between Biogen and the agency were “not typical of other development programs,” but FDA ultimately legitimized the decision by concluding that the interactions “were consistent with the agency’s public health mission given the potential for the first disease modifying drug for Alzheimer’s disease.”

What if all of a sudden the agency STOPS doing this for companies that have a better mousetrap and the real first disease modifying drug in Blarcamisine? That would look even worse for them and I hope everyone on all the message boards call their representatives and the FDA and scream. Meanwhile , a third wammy would be Europe or Australia approving Blarcamisine before them. I think Anavex is in the drivers seat once the full data is released and peer reviewed. Then the partner shows up along with a running PPS.
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