Replies to post #350474 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

shouldn't the FDA look at Avatar independently given the fact that that is what the FDA wanted Anavex to do in the first place?

Sound like the FDA are going to look at AVATAR date once the Clinical Trial Report is on their desk. Hence Anavex are expecting and planning for Expanded Access I would think already with a nod from the FDA, which there would be no need for if approval was coming just around the corner.

[JWC3]

Expect the FDA to approve A 2-73 for adult Rett Syndrome now!

[end2war]

Boopka

As has been pointed out, the rules for approvals in rare diseases do include more "flexibility" which allows the FDA to weigh such thinking. If they did want to push AVATAR to approval and give up the voucher (not likely, IMO) it is possible, especially if they use the soon to read out data from the 48 week OL study which can provide a potential further confirmation. Just saying, it is possible, and we need to see how the FDA advises Missling following the soon to come FDA meeting.

Bet you dollars for donuts that Missling is not going ignore the voucher, LOL