While you might be able to fool the FDA, you probably wouldn’t fool ODAC
If Pazdur writes the SPA based upon a MSKCC-designed protocol, and this trial WILL have a SPA using a protocol designed by MSKCC, ODAC will follow along. There are few things in life that are certain where Pazdur and ODAC are involved, but that would be one of them.
Unless otherwise indicated, this is the personal viewpoint of David Miller and not necessarily that of Biotech Stock Research, LLC. We're on Twitter at BiotechStockRsr