Replies to post #349383 on Anavex Life Sciences Corp (AVXL)

[WolfofMia]

(not saying this summary is correct btw)

No, this sums it up thank you!

[Doc328]

So the question then becomes, what else is going on? RETT will not longer float the boat imho...what else will move the stock? Core strength and undervaluation? It has been an ugly 60 miles of highway the last 7 months. Anybody got any ideas (not saying this summary is correct btw) on the Big Picture?

AD has LPLV May 2022 so I expect results September 2022 (would not be surprised if October, would be surprised if November) -- this will be huge

We will get more data from Avatar hopefully by May or June. If the 7 week response between A273 (meaning old endpoint, endpoint of US Rett and endpoint of trofinetide) and placebo is clearly significant and if 7 week response is at least as good as 4 week response (showing responses don't diminsh over time) --- this could be big (not huge but big).

Other stuff, 371 update, PDD OLE, won't move the needle much but could add a few bucks for a few days.

By Missling's timeline Excellence will report by end of June implying the study is now enrolled. Right..... Does TLD mean topline data or the late doctor? I expect 1H2023, maybe even Feb'ish.

[abew4me]

Let's keep things in perspective.

1) The entire stock market has taken a huge dive...not just AVXL.

2) Anavex is announcing its fiscal results for the 1st quarter this Wednesday...followed by a CC. IR stated that they will be laying out a detailed plan going forward.

3) All of the naysayers that reject a submission for a NDA using the trial results from Avatar DO NOT have all of the information that the company has. It is pure speculation on their part.

4) Anavex can also file for approval with Australia's TGA and the U.K.'s health department...which could put additional pressure on the FDA by the Rett Syndrome community. (Don't underestimate their voice!)

5) Whether you believe that Anavex will file for a NDA or not, doesn't change the success that the P3 Rett trial accomplished by proving our Mechanism of Action (MOA) for A2-73.

6) Having a proven MOA now increases the success of our P2b/3 Alzheimer's Disease trial that should have TLR by September/October of this year. (And frankly, this is why I originally invested in Anavex in the first place)

Lastly, I never saw Too-Tall-Jones throw in the towel before the game was over. (Say it aint so, Ed!) LOL

In all seriousness, you should remember that the FDA has a wide range of flexibility to approve the results from the Avatar trial by itself. With an extremely impressive 7-year safety record, the FDA has to weigh the benefits vs. the negatives(?) of approving A2-73 for the Adult Rett population.

We should know more after the CC this Wednesday.

[blu_1]

Doc I fear is stuck in the past and thinks the FDA operates the same way it did back in the 1980's. This is the 2020's and the FDA aims to be more efficient and expedite drugs to market, especially for diseases w/unmet need. I think Excellence won't be need. Anavex changed that Avatar to a Ph3 trial for a reason, which is fast track to approval.