Biotech Values

[iwfal]

If they want to stop a rush of NDA's that shouldn't be submitted because of the leniant panel they don't have to accept the NDA for filing. Game over

AC's are a MUCH MUCH better bullhorn. How much attention was garnered when Dendreon's NDA was not rejected? vs when the AC vote was positive?

That is a lot different than making cancer patients pay with their lives because a company got a positive opinion from a panel.

I could easily rationalize it - and therefore so could they - as

"It didn't meet our normal criteria (ODAC wants stat sig on predefined primary endpoints) and therefore it is a marginal drug so it really won't matter to patients whether it is approved or not - but it will matter to patients if a lot of drugs are encouraged to inadequately test and therefore delayed."

Do I believe the above is right? No, but well within the realm of what humans can rationalize to suit their own power needs.