Replies to post #346922 on Anavex Life Sciences Corp (AVXL)

[growingpain]

Thank you, E2W. This is an intriguing change, and I am very curious to know if a regulator was involved in the decision to official label AVATAT as P3 or if it was ANAVEX'S decision after accessing the data.

[Steady_T]

There is another possibility that should be added to the list.

Avatar is eligible for a rolling review submission. That means sections of the NDA can be submitted before the entire NDA package is completed.

Here's the interesting part. Much of the NDA for pediatric Rett will be the same as for the Adult Rett. The sections on GMP, drug MFG inspection, safety history etc. will be identical or pretty similar.

So Anavex can get many of the sections of the NDA for Adult in process and approved without filing a complete NDA thus making sure that an Adult approval won't negate the voucher by coming first. It can then use most of the approved sections to speed a full NDA for the pediatric Rett through the approval process.

Interesting possibilities.

[Bourbon_on_my_cornflakes]

WE DON'T NEED NO F'IN VOUCHER FOR ALZ

GOOD NEWS: It clearly means that AVXL intends to try to get A2-73 approved based on AVATAR

It clearly means that AVXL intends to try to get A2-73 approved based on AVATAR

PH3 designation could suggest that TGD is trying to get AVATAR to approval on the strength of the first two Rett trials

Strategy should be to get approval ASAP period.

b]When alz data comes, we should not need any F'in voucher for a quick review by the FDA, alz is such a huge untreated problem that the FDA should give it expedited approval voucher or not.

If the FDA were to treat alz as the same as another acne treatment, the whole FDA should be shut down.

I'm thinking even the lazy bureaucrats aren't that callous and stupid.

Good alz results, we cut to the front of the line