Unless the FDA is just going to tear up their SPA process altogether, rida will be approved. I understand that the FDA reserves the right to depart from their SPA if something unusual happens in the trial, but nothing like that happened here. The drug clearly met all the terms of the SPA - it wasn't even close. The trial was not powered for OS, and so the FDA cannot suddenly demand OS as an endpoint now.
The folks on the AC who are practicing oncologists also understand that in actual practice oncology drugs are often further developed post-approval as doctors figure out ways to combine them with other therapies. That will be particularly important in the case of rida as they figure out ways to prevent AKT activation by combination therapy. Or maybe a combo with a more traditional type chemo drug like ZIOPS's palifosfamide will ultimately prove to be the winner.
Peter
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