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attilathehunt

11/01/23 2:01 PM

#437791 RE: boi568 #437783

"it's prudent to assemble every bit of scientific support before filing an NDA."

If you truly believe that then we will never ever get every bit of scientific support...that could take 20 years....

They data we have now should be enough....unless the data....
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scorman1

11/01/23 2:46 PM

#437793 RE: boi568 #437783

Since blarcamesine has an entirely novel MOA, it's prudent to assemble every bit of scientific support before filing an NDA


please provide a link to where MOA has ANYTHING to do with filing an NDA. The FDA want to see NUMBERS ie clinical benefit, with respective measurements which may include biomarkers, Numbers get crunched by an analytical tool called SAS, which is run on supercomputers and spits out every correlation with p values within fifteen minutes, but I give you grace and call it a day. Management then can spend weeks (not months or years!) deciding which correlation suit their game plan to measure success. But the presumption of defining the MOA is a great over reach of your perspective of the world. Correct me by showing us that link. The only perspective that takes a year or more is "data mining" or trying to extract minuta when your endpoints are NOT stellar.