Replies to post #451381 on Anavex Life Sciences Corp (AVXL)

[bb8675309]

You could have asked him all of that yesterday during the conference call. He was taking questions. Lol

[ignatiusrielly35]

The peer review in its first form was likely only completed recently. No reason to wait for it to be published before giving it to the FDA. The FDA may be reviewing it in prep for a meeting.

[bas2020]

It has been posted here several times... Missling stated mid last year that they would wait for the Excellence trial to complete, in order to pursue the PR Voucher (~$100M). That may still be in the cards, depending upon the outcome of the FDA review of all the Rett data.

[WilliamMunny]

Gute Frage, Missing. Rereading the FQ4 conference call transcript gives a strong hint about your speculation.

[crescentmotor]

I find it hard to believe that the company has not had meaningful conversations with them [FDA].

I don't believe for one second that there have been no exchanges/communications between AVXL and the FDA. After all, that certainly has occurred between AVXL and the regulator in Europe. Note that there is not even a single sentence in 02/07/2024 that mentions seeking approval in AD for 2-73 in the U.S.

Or are they really just waiting for the peer review then go to the FDA? I find that hard to believe as well.

A peer review is not necessary before seeking FDA regulatory approval. Waiting on a peer review gave Missling the many additional months he needed to continue data mining in order to try to fortify the trial results as well as explore the possibilities for regulatory approval across the pond. If the 2b/III could stand on its own in the U.S., a NDA could have easily been filed by the end of 2023. Missling has been stringing this along since December 2022. It failed the smell test long ago just like the extended delay in releasing the Rett EXCELLENCE data. The big question is will the 2b/III data be viable enough for commercial approval in Europe? Missling's credibility has been stretched past the breaking point.

[Steady_T]

The FDA has said that it likes to see peer reviewed papers. Is it a requirement? No. It does represent another review process from a different set of eyeballs.

My guess is that Anavex has been working on 2 or 3 different drug applications of late.

It seems likely that they were working hard on the Rett NDA with the expectation that the trail results would allow for immediate NDA application.
They also have been working on the MAA with the EMA as we have seen with the recent authorization to proceed on AD.
Now that the Rett process is up in the air I would suspect that Anavex is also working on the AD NDA for presentation to the FDA.

There is some commonality between the EMA MAA and the FDA NDA for AD and there are a lot of differences. The EMA requires drug labels and literature in 24 different languages for example although that is not due until 215 days into the CHMP review process.