News Focus
News Focus
icon url

Investor2014

11/04/25 12:07 PM

#505672 RE: Doc328 #505669

But Doc, the Anavex PR and p-values look so convincing and with whatever ABCLEAR group they invent it just keeps getting better. Surely a public company wouldn't say and Publish these things to investors if it was not true? I for one believe much more in Missling and the 58 renowned scientists who know about all the details and signed away their hard earned reputations on an actual peer reviewed paper! Why should I believe in a message board Google doctor? Surely, all that means the CHMP simply must with at least 95% chance recommend full MA approval already next week. I mean, why would the EMA have requested that Missling must file for full approval? CHMP then accepted the MAA, which means right out of the bat there was > 83% chance of approval. Why would EMA/CHMP waste 210 EMA days of precious work on a MAA they can't approve. They knew all the short comings about the coprimary endpoint failing on ADCS-ADL and besides the EMA doesn't care about ADL anymore.

Pretty sure that is what Georgejjl has predicted!!!
icon url

crescentmotor

11/04/25 12:16 PM

#505676 RE: Doc328 #505669

ABCLEAR 2 and 3 are post-hoc -- adds absolutely zero value to the MAA.



Nothing post-hoc about the 48 week trial results for the ABCLEAR1 patients, whose cognitive scores improved by 49.8% over placebo.

where dropouts for treated patients far outpaced the placebo arm



Subsequent changes to the dose titration resulted in dropouts equal to the placebo group.

The OLE and ADNI comparison adds very little value to the MAA



However, it isn't rocket science to project the decline of AD patients at the three and four-year mark since declines have been well documented in thousands of those patients. That's where Blarcamesine shows very convincing efficacy results both in cognition and functional improvement that should not be ignored solely because it is outside of the 48 week trial window. Given the obvious safety of Blarcamesine, common sense argues for approval with requirements for further confirmatory data.

Hopefully common sense will prevail over the anal views of those married to ancient and rigid concepts no longer valid in modern science.
icon url

catdaddy

11/04/25 12:39 PM

#505685 RE: Doc328 #505669

You, Brodkin, Feuerstein are in the same boat. Great company. To put it simply, none of you have a vote regarding approval.
icon url

sab63090

11/04/25 1:11 PM

#505700 RE: Doc328 #505669

Drop outs during COVID Scare seems to be messing things up !

Some negative on this company seem to think that the regulators did not consider this important giving sway to the old medical protocol.into

I'm locked into my opinion and you are also......