Replies to post #173438 on Anavex Life Sciences Corp (AVXL)

[Jonjones325]

Thanks for posting that again. I’ve read it before and it does make sense. Sorry for making you repeat that info.

So I guess, Anavex would file an NDA or the Aussie equivalent after the approval of PDD.

[tredenwater2]

Absolutely right Bio. Picture this, the Alz trial extensions led to a bio marker. In the new Alz trial, the new PDD trial, and the Rett trial this bio marker will possibly show a continuity for efficacy. Much faster efficacy results too in Rett and PDD (secondary endpoints leading to better QOL) unlike Alz where cognition is harder to prove. When the results in one or both of the new trials confirm the bio marker efficacy coupled with the Alz extended trial results (plus safety) we will have a compelling case for an approval. The bio marker is a major breakthrough IMO.


Tred

[tradeherpete]

There is a process whereby a drug which is approved for one indication can be approved without a separate random controlled trial, if it has a Ph2 extension (or sometimes, none at all.)

Thanks Bio, for letting us see what we are looking at.

[Kentucky123]

Seems like a fake jet sweep with the back coming out the other side. Classic misdirection to gain a touchdown.

[ohsaycanyousee82]

If you are indeed correct and I suspect that you are, you may have just Biocheckmated.

[CkFacts]

FDA s WOODCOCK: “ The clinical trial system is broken “

biopharmadive.com/news/fdas-woodcock

Interesting article from Nov 20 by Andrew Dunn reporting on Janet Woodcocks recent repeated calls for Master Protocols.

Would seem like Anavex 2-73 trials in AD ( Australia) , PD (Spain ) and Rett (. USA) fits the bill for an international Basket Trial for CNS diseases ( one therapeutic drug for multiple diseases ) .

Exciting months ahead as data begin to roll in .

Thanks for all the recent informative posts and summaries Bio , Nidan , Xena et al .

GLTAL

[Kentucky123]

Biostockclub your PDD trial looks to be moving at the fastest pace of any of our trials. Looking better and better.
Blessings.