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-