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Posted On: 09/07/2022 12:31:33 PM
Post# of 155869
Re: Evil Rabbit #128438
Hopefully we will hear at least 2 things on the Sept 30 call:
1. That the team did indeed submit all of the necessary data to have the hold lifted (past tense)
2. Some guidance as to the window the FDA has to respond / lift the hold - and hopefully this is a short window.
I fully expect that we'll get the data submitted - maybe it's already submitted (who knows). But it's item #2 that concerns me, as i have no confidence in the FDA trying to help us out. Hopefully i'm wrong about that and it's a quick reply.
1. That the team did indeed submit all of the necessary data to have the hold lifted (past tense)
2. Some guidance as to the window the FDA has to respond / lift the hold - and hopefully this is a short window.
I fully expect that we'll get the data submitted - maybe it's already submitted (who knows). But it's item #2 that concerns me, as i have no confidence in the FDA trying to help us out. Hopefully i'm wrong about that and it's a quick reply.
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