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12/24/18 8:32 AM

#175947 RE: OFP #175938

Opinion stated as fact:

I disagree. Using "historical U.S. data" when the U.S. is in the middle of trashing their own procedures would be foolish.

Using "historical U.S. data" developed for failed drugs with sloppy diagnostics would be rather unscientific.

Using "historical U.S. data" for a trial using precision medicine protocols with state of the art diagnostic methods would be absurd.


Very rarely in the face of extraordinary results in diseases that have poor treatment alternatives and in populations in which recruitment is slow/difficult. 2-73 has 1 of those 3 criteria. There is no credible reason to EXPECT early approval. To say otherwise is UNHELPFUL. A rational investor would look to "historical US data" for reasonable timeline expectations.