Replies to post #115420 on Biotech Values

[iwfal]

While you might be able to fool the FDA, you probably wouldn’t fool ODAC

Has there ever been a case where a company legitimately met their SPA and then the ODAC shot them down - essentially saying the FDA was dumb to sign up to that protocol? (note the word 'legitimately' - to exclude Satraplatin).

This could make for a biogeek soap opera!! -g-

[AlpineBV_Miller]

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.