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Re: Boopka post# 350474

Thursday, 02/10/2022 10:42:21 AM

Thursday, February 10, 2022 10:42:21 AM

Post# of 517672
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
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