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clock Created with Sketch. 23/07/23
15:40
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Originally posted by JB1975:
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Look closely at the data I just posted. Not going to pretend to understand the science behind the assay, but I do have a grasp of statistics, and those stats look pretty good to me. one adequate and well controlled trial . But its possible they may have enough - the way they are presenting what they have seems to me that they are hail marying - that is hoping to get a pass from the FDA on safety, on unmet medical need, on some good survivial data etc, without needing to get more data to show that the potency assay they have is really really reliable in ensuring the product is potent.
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"I personally don't think that currently they can have enough data to satisfy the FDA's need to have at least one adequate and well controlled trial." without needing to get more data to show that the potency assay they have is really really reliable in ensuring the product is potent.
(20min delay)