Biotech Values

[DewDiligence]

>One of the problems with calibrating the FDA is that you only get to see the FDA's side of it when the drug is eventually approved or when it makes it as far as an AC.<

There’s a third way: when the fallout is so severe that Congress holds public hearings to find out what went wrong. This is how the FDA’s side of the Erbitux debacle came to light in 2002.

Your main point is well-taken and is the reason I generally reserve FDA bashing for cases where a drug is already approved in at least one major jurisdiction such as the EU.