V1,
I'm glad you're not the only one who was confused. I don't know what the odds are, but if they have these long term responders to parade in front of the ODAC, then perhaps they'll get the same response AZN did for Iressa.
I would guess the FDA's apparent perversity comes from the BRMAC acting in an ethical fashion, and then a statistician from some other part of CBER(?) said but, but, but . . . If the committees don't have statisticians sitting in, they ought to. Of course, the extra arm the FDA said they wanted would have cost a bundle, and probably slowed things down. Not sure what the ethics of the extra arm are. Has anyone read the briefing documents for the IDPH drug for the same indication? I was wondering how they compared (probably, given different trial design, they don't compare very well).
Happy viewing, V1; looking forward to the updates.
Thanks, Rick.
Cheers, Tuck |
