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Re: NoBuddyNoz post# 846

Wednesday, 10/10/2007 8:42:34 PM

Wednesday, October 10, 2007 8:42:34 PM

Post# of 9809
McDonald v. ODAC

McDonald is biased alright, he's biased towards providing patients with the greatest chance to survive the horrors of GVHD without bombarding them with systemic steroids and immunosuppressives which cripple their immune system. ODAC, on the other hand, is biased towards their own regulatory processes, precedent and perceived intellectual prowess.

Good thing ODAC doesn't make the decision here. It would be a shame if something McDonald has spent over a decade working on would be so quickly dismissed by bureaucrats who are given an hour or less to give their informed opinion on the drug.

The data summarized in McDonald's abstract is Total Treatment Failures at day 50 and 80 for prednisone responders and is not part of Dor's ODAC brief. Given the fact that McDonald was likely involved with any data compilation work after the June 13 meeting it may be indicative of where the focus lies.

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