Thursday, September 24, 2020 12:04:47 PM
A few examples:
On PPHM one of the main longs (forget the name) argued that the stat sig subset should garner an approval despite the fact that overall patients did worse on the PS mab. PPHM did not even submit for approval.
On ONTY many argued that the key subset should have garnered an approval. They never even filed for approval.
On IMGN Gary argued the FDA screwed them as it was P<.05 of OS on a key subset despite the fact the company did not allocate sufficient alpha. They never even filed.
Expect the same here if LP spins a failed trial as I think is likely.
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