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rayovac812

09/18/25 12:54 PM

#500969 RE: imho #500955

So what is your definition of what "sufficient" means to the EMA? After all, it failed the ADL endpoint.



ADL is not an EMA endpoint. If it were an endpoint, this would not have been accepted for review, in the first place. Opinions most times do not carry the weight facts carry, but you know this. Just do what you are going to do, without actually trying to buffalo those with a firm grasp of conceptual reality.

It also seems it was under-recruited, etc.



You should have gone here alone. Lets examine this thinking though. So here we are. With the trial data they do have, they have ascertained precise genes for which 2-73 works superbly. It is why the field accomplished are using the precision medicine moniker.
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Hoskuld

09/18/25 8:30 PM

#501023 RE: imho #500955

Rayovac responded already and all I have to add is that, incredibly, the power of the trial was just fine with only 500 patients to start the trial. A second trial would have taken all risk out of this process but it is what it is now.