Replies to post #427859 on Anavex Life Sciences Corp (AVXL)

[powerwalker]

Please provide quote.

[abew4me]

Mr. Palmer...I think he said that he was going to aggressively approach the FDA...which is much different than claiming that he was going to pursue the FDA for Accelerated Approval.

And remember, Dr. Jun Kin came aboard in early January and has undoubtedly made several recommendations to TGD that will increase our chances of getting FDA approval.

Perhaps Dr. Jun Kin told Dr. Missling to wait for the OLE before approaching the FDA. Or...Perhaps Dr. Jun Kin told Dr. Missling to wait for FDA approval for Rett...and then repurpose the drug for Alzheimer's Disease. (Which was the original game plan anyway, IMO)

One other thing to remember, TGD told everyone at the ASM that we will enjoy seeing the P2b/3 data once it is presented in the 2H of 2023. (paraphrasing)

The next 3 - 4 months should be very exciting for those of us that have the patience to wait.

[Steady_T]

Accelerated Approval does not mean the approval process for an NDA is any faster than the regular approval process. It means that surrogate endpoints can be used in place of efficacy endpoints that might takes years to complete.

The only way to get a faster approval process is Fast Track or Priority designations. That shortens the approval time frame from the usual 10 months to 6 months.
Pediatric Rett has Fast Track designation. AD does not.


Biogen's AA was 10 months after the NDA was submitted.