Replies to post #505666 on Anavex Life Sciences Corp (AVXL)

[La Flaca]

I won't judge you - I think you're a critical thinker with a bias. I'm just asking you to set your bias aside. I really am interested. I consider myself a critical thinker (legal training) but I know I'm biased the other way.

[crescentmotor]

If you [Doc328] were a voting of member of CHMP, what would be your vote given lack of traditional Phase III trial?

He has repeatedly indicated that he views AVXL as only having a 4% to 5% chance of conditional approval. That's a convincing tell as to what his vote would be.

[Doc328]

Most importantly, a rejection means millions of lives sacrificed for 3-4 years (while another phase III trial is run) to dot all the i’s and cross all the t’s despite having all of the validation and confirmation that Blarcamesine works AND is SAFE

Lol I'm one of the few posters who provides links to back up my statements -- ask others to be objective.

I've outlined many times why I feel approval will not happen (read my posts since 12/1/2022). I would vote no without additional trial. ABCLEAR 2 and 3 are post-hoc -- adds absolutely zero value to the MAA. This has generated a hypothesis - now test it. The OLE and ADNI comparison adds very little value to the MAA. The focus is on the 2b/3 trial - where dropouts for treated patients far outpaced the placebo arm, where the SAP was not followed and 1 coprimary endpoint failed. Other drugs with milder (lecanemab) or equal severity (donanemab) had no trouble with significant slowing of functional decline during the trial.

I still think there is only 4-5% chance of any type of approval (to allow actual marketing/sales) based on this MAA. I expect either withdrawal or denial in next 2 months. Missling should have done the trial. It would be wrapping up right around now.