dado, I don't often disagree with biostockclub (and now, you), but I don't think the approval of adu* is helpful to Anavex and blarcamesine.
My reason is based on no competition is better than even bad and flawed competition. The fda has now doubled down with the Lilly decision, and will triple down with BMY re-entering the AD field, on its decision, favoring Biogen. It has dug in on the amyloid theory as being the primary endpoint of determining if a drug should be approved for AD. Which creates a hurdle that wasn't necessarily there before the Biogen decision.
We have seen the fda's staff lie to the adcomm group (no AA or surrogate findings it claimed), so it has established a pattern that it will do what's necessary to see that its end goals are met.
So, Anavex takes its data from 450+ participants and presents it to the fda. In the data, blarcamesine is show to improve cognitive performance, but does not clear amyloid as amyloid is waste and blarcamesine stops waste, but it doesn’t clear. These results put fda in a dilemma: no amyloid removal, but cognition. The current AD staff at the fda decides, that since amyloid removal is more important than cognitive improvement (on which its previous decisions were based), that Anavex needs to perform another larger P3 trial to determine whether amyloid may be removed and/or more data to ensure cognitive improvement is achieved throughout the participants population and/or any other outlandish reason it concocts.
The fda reaches this decision because it wants to give Biogen, Lilly an, possibly, BMY two-four year head start that allows each to r-coup its R&D funds spent over the last three decades. It might know it will eventually approve blarcamesine, but the more hurdles it places in front of Anavex, the less impact it will have when blarcamesine reaches the market.
I think the only way Anavex gets a fair shake is if my “Profiles in Courage” champion, Joe Manchin, and/or Elizabeth Warren convinces President Biden to dump the whole crew at the fda who involved with this decision.
I believe if the system were fair, Anavex would be the first approved AD drug in 20 years. But it is not fair and rigged against innovative biotech firms, which is why so many get bought out at values below what those companies’ s/holders should receive.
My hope is that Down Under, TGA moves positively on blarcamesine next week (I think TGA and Anavvex looked at the first 225 in the P2b/3, especially if positive OLE results were experienced by the placebo group) as July 1st is the start of the Australian government’s fiscal year, which allows the government to show its empathy for those afflicted and allows Anavex and the knowledgeable public to put some pressure on the fda.
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!![/quote]
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