If 273 clearly works, no second P3 will be required.
I can generally agree with this broad generality, LOL, but what it fails to appreciate is what is needed generally to prove A2-73 "clearly works" involves a series of tests that confirm each other to achive that clarity in the word you have used, "clearly."
The issue is not only what data is produced, such as the magnitude of the effects, the percentage of participants that enjoy positive effects, i.e. "responders" the statical probabilities and effect sizes, etc., but also the elements contained in the study that enable the sponsor to show the FDA that these data points are "confirmed" and whether that latter confirmation can be found in the initial study data, and/or in other supplemental data that AVXL can offer. How many studies are necessary for "clarity" to emerge? That is the ultimate question of whether the data meets the endpoints sufficiently to gain approval.
What does the FDA think about the data after evaluating it?
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