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Wednesday, August 02, 2006 9:54:58 AM
DR. OKARMA: Right. Well, the, the application here for our own IND is what's occurring. The steps first are to submit to the *RAC - that has happened. Once the RAC buys off of the application, then we file with the agency, and that is on track to happen very soon. So we would hope to actually begin enrolling subjects by end of the year under our own IND. We have not yet announced the actual tumor type; I can tell you that it is within the hematologic malignancy arena and the reason for that is the trial is designed to demonstrate a direct impact on tumor progression, which, as you know, has really not been described by anyone in the cancer vaccine space before and that is very difficult to do in prostate cancer because it's hard to get objective measures of tumor progression. So that's as much as I can tell you now, and when we're actually enrolling, we'll announce it.
Q All right. Thank, thank you very much.
DR. OKARMA: Welcome.<<
[*RAC: The NIH established the Recombinant DNA Advisory Committee (RAC) on October 7, 1974 in response to public concerns regarding the safety of manipulating genetic material through the use of recombinant DNA techniques.]
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esammee, great post to fight off micro. my goodness, can micro lie. let him come over here and try that junk-----i'm guessing he'd be banned from the board after a few warnings plus he'd probably be hearing from geron and the sec.
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