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Bourbon_on_my_cornflakes

06/27/25 1:34 AM

#492473 RE: skitahoe #492472

Once you've spent your money and provide your data while applying for approval, then they may ask questions that you can't answer because no one asked the question before.



True. But now with the EMA, they are asking the "do or die" approval questions. So if what is being asked at the clockstop are softball questions.....that may influence willingness to spend on PR.

If EMA approves and AVXL gets the story of a safe, effective alz pill out to the American public, then some sort of accelerated approval becomes a possibility.
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boi568

06/27/25 1:42 AM

#492476 RE: skitahoe #492472

The onus to execute the proper design is always on the applicant, FDA or not, as it should be and has to be.