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skitahoe

05/10/24 6:03 PM

#690451 RE: NotSure2 #690445

I think it's clear that no RFI was requested, if the UK doesn't act in the next two weeks they've simply failed to meet their own 150 day deadline. To me it's no big deal if that's the case, the FDA has frequently moved PDUFA dates, this would be no different whether the UK people announce it, or not. It's a self impose deadline, I still expect them to make it, but it's not the end of the world if they fail to.

I frankly agreed with others that we'd not see anything unexpected in the quarterly, so I'll admit a little surprise in acknowledging not being asked for further information, but I'm thrilled that they said it. The next week or so are nervous time, it could happen any day.

We'll see how the market takes the news on Monday. I'd expect the bashers will be throwing out everything they can think of to try to hold down the gains I'd expect while waiting for the UK decision.

Gary
Bullish
Bullish