Wednesday, June 18, 2025 1:48:13 AM
Lab, while I agree with you that they have a plan to move trials, and other things forward. I do believe that it's all starting with UK approval. If that were to be delayed by some requirement the UK insisted on, I suspect that they'd have to rethink their plans.
I don't believe that will be the case, not after this much time. If the UK were going to insist on something more from the company, they would have insisted on it a long time ago.
The FDA of course has their PDUFA dates, on many occasions I've seen them delay the date, but rarely if they're not approving. CRL's almost always come by the PDUFA date, approvals often at least a few days, or even weeks, before.
Gary
I don't believe that will be the case, not after this much time. If the UK were going to insist on something more from the company, they would have insisted on it a long time ago.
The FDA of course has their PDUFA dates, on many occasions I've seen them delay the date, but rarely if they're not approving. CRL's almost always come by the PDUFA date, approvals often at least a few days, or even weeks, before.
Gary
Bullish
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