I don't know what your definition of "we got this" is, but it doesn't match mine. I have never said "we got this."
As for "statistical finessing," I am old enough to remember Doc himself conceding that the Kun Jin .025 test was legit support for the claim that the 2b/3 AD trial succeeded, although saying it required further validation for purposes of regulatory approval. Since then, and without further information, he has managed to convince himself even the .025 test here can't be true. Confirmation bias, I guess.
As I and others have explained to you, you have nothing more than your opinion to challenge the fact of the 85% EMA stat and, frankly, your bias is on display with every post. You have even reached the point of persuading yourself of a significant CHMP "validation" hurdle upon filing an MAA, for which there is no evidence whatsoever, while ignoring that Anavex has already received CHMP validation through its green lighting of an MAA several months ago. CHMP didn't do this without first seeing all the relevant trial data. Do you think they didn't read the critical few pages of the SAP for context?
With the exception of his earlier misstep regarding conceding the validity of the .025 test, Doc has missed no opportunity to take every adverse inference he can find. Even today's questioning of the brain volume data, for example, which is really a stretch, given the reliability of MRIs and the clear import of retaining brain volume in AD. (If I recall correctly, the weakest Anavex p value stat there related to the parietal lobe which, as it turns out, is less affected than other brain regions during early stage AD. A weaker -- but still stat sig -- p value for that lobe is therefore consistent with an inference of blarcamesine's clinical effect on the course of AD.)
In older posts, Doc has noted (1) his expertise in MS (a Biogen speciality), as well as clinical trials; (2) his personal acquaintance with the former Biogen CSO (before he was fired for his role in the Aduhelm scandal); (3) his willingness to use Aduhelm in his clinic (before Biogen withdrew the drug); and, (4) the opinions of his peers on the specific length and n of a recommended second 2-73 AD trial (certainly not a Facebook group, my inference being that they are a competitor's expert group). The Biogen connection seems apparent.
I think Doc believes what he says, but I also think he is professionally anchored as an Anavex opponent; I don't believe he will ever change his opinion of Anavex's research and trials. And this is a familiar phenomenon: As Max Planck famously said, science advances one funeral at a time. (I expect in this instance we won't have to wait quite that long.)
A great deal of the arguments against the legitimacy of the Anavex claims involve the extended time lines we are experiencing. The unstated premise is there is only one possible schedule in which every CEO can proceed in drug development, and a failure to conform to that schedule demonstrates a drug has failed.
This is a behavioral analysis, and perhaps an historical analysis, but it is not a form of scientific proof. Missling clearly does not fit the mold in his communications; he really says very little compared to other CEOs. This could be from personal preference, his history with shorts in 2015, his choice of advisors, or his perceived need for initial concealment when challenging scientific orthodoxy.
On the other hand, if Missling were conducting a fraud he would not invest in and be able to produce supporting research, attract legitimate scientific talent such as Sabbagh and Jin, or maintain good financials. He would not have been able to get any form of CHMP approval. He would do much more in the short term to pump up the share price (which has been conspicuously lacking).
My conclusion is that the company understands what it is up against, both in the challenge of demonstrating fundamentally new science and overcoming entrenched old guard opposition. It therefore must take the time to marshall all its evidence -- certainly, including the almost completed AD OLE.
The curtain is about to be pulled back on the data, and much of this scientific controversy will be resolved. In the relatively near term, we will get answers from regulators and we will know the fate of the company. Meanwhile, as Steady likes to say, the rest is entertainment.
