Replies to post #428159 on Anavex Life Sciences Corp (AVXL)

[bas2020]

I believe you're right, since the OLE started in Oct 2019. Many have completed their 96 weeks.

[abew4me]

When Anavex submits the NDA for Rett, the FDA requires them to submit all of the data related to A2-73...so they will most likely submit the OLE data using the ~350 patients...rather than wait for the completion at the end of July, 2024.

Side note: If Anavex has had this information for some time, I would think the TGD is privy to the results...and thus, it could be another reason why Dr. Missling chose to buy the 320,000 shares of AVXL when he exercised his options.
(I'm pretty sure this doesn't violate FCC insider rules because TGD was forced to exercise his options before they expired...but maybe SAB or boi can enlighten us?)

[WilliamMunny]

Well, if Anavex has P3 OLE data for a substantial chunk of the patients, one might imagine it to quite positive if Missling is suggesting that the OLE could be used as the confirmatory trial…

[kund]

Anavex already has P3 OLE data for ~350 patients who already completed the OLE

how do you know this? extrapolating? use PDD ole as benchmark and you will get real picture.