Replies to post #102719 on Biotech Values

[DewDiligence]

I think the FDA really doesn't have any rhyme or reason as to how, why, or when they approve something.

If you actually bothered to study the FDA’s analysis—e.g. in the case of generic Lovenox—you would realize how silly your assertion is.

[jq1234]

they delay (like Provenge which showed clear evidence of efficacy).

I am a big suporter of Provenge. However, to say it had clear evidece of efficacy in original BLA is a stretch. Remember, it failed its primary endpoint. The efficacy you stated was from post hoc analysis. FDA should NEVER approve a drug from a study that failed its primary endpoint. They need to run a better trial. They did, and it got approved.