Monday, August 22, 2005 1:44:59 PM
From what I have read following the Merck Vioxx verdict, I think your FDA "gatekeeper" is going to be issuing more, not less, "no fly" orders at its checkpoint, absence of established toxicity notwithstanding. Ironic.
Expect approval will be easier in China, where those $ 50 VCRs come from. But, since our patent means nothing to them, they won't buy it since they can make it cheaper.
Re possibility that fact the Panzem NCD trials are still enrolling may be due to insufficient patient applications: How does a referring doctor have to handle this? I understand that the trials are for advanced cancers, so it is a given that some prior indicated and approved therapy has failed. But does a doc have to say look, this has promising pre-clinical possibilities, but you ought to try Avastin (or Thalidomide, or some other off-label thing)first ?
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