Replies to post #453734 on Anavex Life Sciences Corp (AVXL)

[plexrec]

WM---" is very beneficial for Anavex's cause."--so TGD needs to step on the accelerator and get this thing approved ASAP----ridiculous the time this has taken!!

[frrol]

Anavex has not made "claimed benefits of better sleep, reduced blood pressure, improved tau levels" in our AD 2b/3 results. In the paper, we will very likely see the results for the latter, and may see results for the first two. They are most likely not stat-sig, as with ADL (and possibly even no discernible effect). The CSF pTau results will be considered in regulatory evaluations.

Not stat-sig would be unfortunate, though it would not rule out an approval. It just makes it less likely than otherwise. If pTau levels don't credibly drop, it will be helpful to have a plausible clinical explanation.

[Jonjones325]

Let’s see if they learned a lesson from the previous adcom fiasco.

I’m sure no one wants to resign. Maybe we’ll get another Kun Jin out of it.

[sage4]

Yes "good timing" is quoted from Dr. Missling in Q&A section of the last CC a month ago.
It wouldn't mean much but interesting. What bothers me is that he seemed not began the dialogue with FDA yet for AD trial? Even for A.A that he said he'd pursue earlier? Hope it's just mis-spoken.

Tom Bishop: Good. Where do you stand with the FDA as far as Alzheimer’s goes? I was really pleased with the news about the EMA, but what about the FDA?

Christopher Missling: Yes, it’s a great question. We actually have noticed that last night we saw the release from Eisai (dropping their Aduhelm) ......................................................... And this gives us actually probably an interesting position from a timing perspective, to prepare now a dialogue with the agency to share our data with the small molecule, which has the advantage of being easily administrable, does not have any challenging procedures. You don’t need a PET study upfront, you don’t need an MRI study upfront or during the treatment, and you can just go to the physician and be assessed and have Alzheimer disease, and the physician will say, take this capsules or pills and come back in a few weeks or months again. And so this is really a big advantage from our procedure. There’s also no requirement to have a demonstrated level of a better in the brain because in our study it was not required. We measured a better in the brain, but it was not an entry criteria.