Biotech Values

[DewDiligence]

Re: Pazdur in the news again

[From the Yahoo IMCL board]

>>
Re: Pazdur in the news again:
by: DewDiligence
05/19/05 05:53 am
Msg: 304616 of 304616

>> Pazdur's rise and the attitudes expressed in this article by the other FDA official would seem to ring very ominously for the likes of DNDN and many others.<<

Dr. Martino (the other doctor mentioned in the WSJ editorial) is not an FDA employee but rather the Chair of ODAC.

I agree that Dr. Martino and those of her ilk are scary for companies like DNDN, but I think DNDN’s Provenge will not go to ODAC – it will either be accepted or rejected by the FDA without guidance from ODAC (IMHO).

(The situation for Provenge is not dissimilar from the Erbitux case, where ODAC was deemed superfluous because the side-effect profile of the drug was mild.)

>>It will eventually be determined why Iressa works and in which sub-group. Why pull it from the market now?<<

I don’t think they will pull it. I will go even further and predict that no cancer drug will ever be pulled from the market because of low efficacy – only because of unforeseen toxicity.

>>And in general Pazdur is very scary guy.<<

I certainly would not want to find him in my hallway in the middle of the night! Regards, Dew

[Posted as a reply to: Msg 304614 by that_waksly_wabbit]
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