Replies to post #347001 on Anavex Life Sciences Corp (AVXL)

[nidan7500]

Steady T

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.

Really, really nice work T...thx.

[jimmy_mcyoloswag]

If only we had someone on board with detailed knowledge of the intricacies of a rolling NDA review with the FDA. Oh wait..

[tredenwater2]

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.

Steady, who would know better than a few veteran Fda paper pushers?

[end2war]

Yes, that is basicially what I was trying to say in my post. And, I am growing increasingly thinking along those lines. It is my thought that TGD has had this strategy to using the rolling approval all along, and with the necessary AVATAR data in hand, he is finally in the position to present the plan to the FDA. They need to see AVATAR data before they can evaluate and grant the rolling submission request, which I suspect has just occurred.

A major point that TGD will have been discussing with the FDA, IMO, is how to preseve and use the voucher; which, we seem to have concluded from the statutory language, requires the pediatric approval be first. Maybe to get into the voucher discussion, there was a peek at the EXCELLENCE data so they could show that to the FDA and line up a possible rolling submission that aims directly at the pediatric approval, not the adult approval!