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plexrec

01/15/24 3:00 PM

#447836 RE: Jonjones325 #447821

" there’s a lot riding on this peer review"--this we all know !! Is there a "Pony Express" around to get this publication ASAP ???????
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Investor2014

01/15/24 3:45 PM

#447838 RE: Jonjones325 #447821

That paper, if worth its salt, will also establish that the ADCS-ADL co-primary endpoint failed and thus that the all endpoints met statement was false.

Anavex and everyone else but the class action lawyers can now hope that approval and/or some other reason results in a share price increase making any action moot.

I don’t think we will see that peer reviewed paper until Anavex and their lawyers feel certain that the risk of litigation has hopefully subsided.
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boi568

01/15/24 5:00 PM

#447849 RE: Jonjones325 #447821

I will be very interested to see what's in the peer reviewed article, but it is no longer as big a deal for me since the announcement of the EMA green light.

The primary purpose of the upcoming paper is to persuade regulators that blarcamesine should be approved for Alzheimer's Disease. Its secondary effect, if not purpose, is to promote demand by investors to buy stock. I take it as a given that EMA staff have seen the data that will be disclosed in the upcoming paper (and perhaps more than that in the form of OLE results).

So if the paper shows some really good data, which I rather expect now, it should certainly help legitimize the science and the trial in the eyes of Wall Street and perhaps even the general public. But if the paper is not quite as strong, my evaluation will be that the EMA is quite willing to consider approving blarcamesine anyway. The article will not be news to them, My assumption has been from the beginning that the ADL endpoint was not met by a comparison of the means test, but that this is not nearly as problematic as some posters here are making it out to be. There are other ways for the trial to have succeeded.

I'm also aware that the EMA and the FDA tend to be in agreement when approving or disapproving a drug, so I read the EMA's recent action to bode well for an eventual NDA with the FDA. Like everyone, I am looking forward to seeing the paper, but I am past the point of believing the paper will provide the answer to the fate of the 2b/3 trial. The EMA green light gives us more information on that front.