Wednesday, November 27, 2024 11:40:40 AM
I’m willing to bet 3 month data is good and gets them approval
As a general rule a secondary endpoint means little after the primary fails.
The only reason why there is some hope is that we really do not know for sure what the FDA really needed to see to resolve the CRL from the previous trial. If the FDA just did not accept the first trial as worth much, then you can stick a fork in it.
It is not unreasonable to hope though that the FDA accepted it to some extent as establishing efficacy, but wanted to see confirmation with the CMC issue resolved. If so, there is some chance. Particularly if the primary was trending well.
Still, always a long shot betting on such.
Do agree with the EU/UK making the company of some value. Need to wait for the dust to clear in the upcoming financing.
Recent OTLK News
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