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manibiotech

03/25/20 12:08 PM

#273072 RE: Doc logic #273071

The rules right now are objective . She is asking to make them subjective . Not sure what you are reading
E.g. .. following p value of 0.05 as cut off is objective no matter who applies for approval . By keeping it fluid is subjective
Etc etc
Not that I agree with current FDA procedure , and I would want more progressive and rational changes to be implemented
But what you are saying is other way around .