Thursday, December 30, 2004 6:44:00 PM
I expect the approval process to be analytical, based on previously obtained genomic data. (obtained during the formal phases of the drug approval process).
I expect all of the players in the pharmaceutical arena are quietly biding their time awaiting the go ahead from the FDA. Their data has been available to them forever, they have had more than enough time to distill the classifiers from the data. They have already kept a large portion of their data untouched and 'clean' in order to facilitate the verification process as soon as the FDA establishes the guidelines.
So, yes, I expect drug classifiers to be the next big push in the pharmaceutical industry. They will heavily leverage the Vioxx and Celebrex issue to promote them, and personalized medicine will have arrived.
I will not necessarily sign up to the 2005 date that you have proposed, as the development of the playing field seems to be progressing at a snails pace, but the players are ready whenever they blow the whistle.
regards,
frog
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