Replies to post #480604 on Anavex Life Sciences Corp (AVXL)

[BostonSportsNut]

TREMENDOUS POST!!

But Mommy its not fair, I went to 4 years of College and she skipped college did drugs went thru rehab, and now is a world famous rock and roller.!!!!

Let them bleat on and on, thats all they have.

[crescentmotor]

So all this fuss about single trial, low n, and the missed irrelevant ADL endpoint seems more like a continuing sandbox tantrum than a serious argument.

That's because Investor2014 and Doc328 only have those nuanced crumbs and details left in their worthless attack arsenal. Even the transient dizziness adverse effect has evaporated as a meaningful concern. Neither one posts with a global perspective because that sort of big picture evaluation easily establishes that Blarcamesine is head and shoulders better, from both an efficacy and side effects perspective, than the current Mab offerings. The recent peer review article offers vigorous support for Blarcamesine and the MAA is under active review. Nit picking bashers will soon be relegated to the curb where they belong--the big picture is now in focus.

[imho]

Good post that basically captures my train of thought also. A key paragraph:

"It doesn't matter that the company used and then abandoned an Odds Ratio analysis; it doesn't matter that the 24 hour turnaround right before 2022 CTAD resulted in a bit of data correction; it doesn't matter to the EMA that the MMRM analysis came late, or it took Anavex a long time to get the MAA together; it doesn't matter to the EMA that the whole process may offend the sensibilities of management consultants, or business executives, or competitors."

I would make one change to the above that captures my thinking exactly. I would replace "It doesn't matter" with "It may not matter". The whole approval decision may hinge on the regulators accepting Blarcamisine's minor flaws with respect to the major flaws of the Mab's.

IMO, the FDA's acceptance of the Mabs was an inflection point. After 30+ years of R&D failure of Big Pharma, the FDA caved and IMO signaled that new rules must be adopted. Main street is playing by the old rules and as such AVXL stock is punished. Main street and the regulators opinions are about to diverge, IMO.

The JPAD authors did not say that Blarcamisine was perfect, but that it can be a favorable alternative to the Mabs. The unnamed scientific "peers" agreed and the paper was published. Given that, I think the unnamed EMA regulators may also agree, and therefore approve. Faith vs fact? Judge for yourselves.

It is not that Investor and Doc are wrong with the facts as we know them. But, "it may not matter."

IMHO

[sab63090]

boi568
Naturally, I hope you are correct from the endorsements received from the peer group and acceptance after filing the MAA, but concede that the promise made by Missling was NOT kept, i.e a full report on the OLE, rather he has pushed this down the road and I personally was not impressed with his delivery. I could not see the audience nor his calm and unexcited "presentation" full of past performance achievements and nothing new.

I doubt the room was full, but will report anything I receive here should my query be answered.

The stock reaction was not really bad, but was a big disappointment to me. It held pretty much to the lows of the last 3 days.

🤕