Ocyan OT re: DORB.ob & orBec
<<<"I wondered if that harshness was a kneejerk reaction after the relatively soft review of the Provenge BLA and the ensuing mess.">>>>
Yes I think so, but not necessarily by Pazdur. I don't think he had veen seen these briefing documents before; they looked un-supervised by ODAC standards.
<<<"recommendation for OrBec would serve as an example that absolute approval authority for any cancer drug remains with him and the FDA">>>>
While I think it's possible, dare I say likely, I don't think politics plays much of a part - in fact I think that once safety is out of the way, medicine & regulations trumps politics in general when it comes to NDAs.
Before I get anyone annoyed: I'm not slighting Provenge here; I am not saying it was 100% medicine & regulations and 0% politics that shot it down. But I think that politics has a minor role, perhaps only to break ties.
Actually DORB.ob has declined in price today and while I don't make stock recommendations, at 45c, well like March 28th, you never know........
"....on the biotech battle-field, you need some élan...."