Replies to post #430982 on Anavex Life Sciences Corp (AVXL)

[Jonjones325]

The number of improvers will help seal the deal for AA. Seems that many here believe the number to be quite high.

And we keep the amyloid crowd happy. Big plus since their influence runs deep.

A safer easier way to reduce amyloid has a nice ring.

[Steady_T]

I don't think that Anavex has to wait for Rett approval before filing for an AD NDA. They just have to wait long enough to ensure that Rett is approved before AD.

Given that Rett is Fast Track which means a 6 month approval time frame after NDA acceptance and AD has a 10 month approval time frame after NDA acceptance, seems to me that the AD NDA can be filed after the Rett NDA is accepted with a pretty good safety buffer that AD won't be approved before Rett.
After an NDA is submitted, the FDA has a 60 day window to decide to accept or reject the NDA filing. Once the NDA filing is accepted is when the approval time frame clock starts.

The delay on obtaining the Rett voucher is not that long.

Also Rett has rolling submission for its NDA and AD does not. That also can shorten the delay between the two approvals.

Rolling submission means that any completed section can be submitted to the FDA for review. The time window for approval doesn't start until the last section of the NDA is submitted so rolling submission doesn't lead to faster approval in terms of a shortened approval window. That is a function of Fast Track designation. What it does do is allow the company to respond to any questions or issues the FDA has with a submitted section before the last section is submitted. So if there are any issues with the early submitted sections they can be ironed out before the approval time frame is started and not delay the approval.

Of course many of the NDA sections will be the same for Rett and the AD NDAs. That means most issues will be worked out in the Rett approval process and will not delay the AD approval process.