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Investor2014

08/21/23 12:08 PM

#428010 RE: BAR123 #428009

To do anything at all with that voucher, Anavex first must have it awarded!

Or they will just use the voucher to speed up the alz approval.


If approval for Rett actually happens say by end 2024, it would in any case have been a lot faster just going flat out for AD.

Obviously the P2b/3 just isn't good enough for that. Meanwhile Anavex is still sitting around one quarter later considering having a chat with the FDA about a maybe pathway for Accelerated Approval.

Steady_T

08/21/23 2:30 PM

#428047 RE: BAR123 #428009

Probably not a good use of the voucher. Here's why I think that.

Rett will hit the market quickly and will command a very high price. That will be a big revenue stream.
AD approval will rapidly cut the price of the Rett drug and it will take a while for the AD revenue stream to ramp up impacting the revenue stream.

Much of the NDA for Rett will be reusable for the AD NDA so that will cut the prep time for the NDA down significantly. Presumably the company is already working on the NDAs for both drugs currently.

The company can apply for priority review for AD once the Rett NDA is in the hands of the FDA. The FDA doesn't have to grant priority review but it might. Priority review has the same effect as the voucher on time frames.

Selling the voucher funds additional trials for other indications immediately while it will take some time for the AD revenue stream to ramp up.