Assuming for a minute the MSS CRC trial is a great success the FDA conundrum will come down to the question: “Would you die for a p-value?” I would not bet on their response (especially in light of their pandemic emergency response to Leronlimab trial results with severe/critical COVID) but suspect for a cancer that is cutting a wide swath through our country and physicians and patients clamoring for anything when they currently have nothing, the right moral response, especially in light of other Leronlimab data with a cancer indication suggesting it is not a fluke, would be conditional approval with confirmatory phase 3.

An easier bet will be the response by BP and investors willing to open their wallets.