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CEL-SCI Corporation Message Board

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  • cmegladon cmegladon Sep 24, 2009 3:00 PM Flag

    The hiring of CRO is such a tell. If you

    I stil say the CRO is meaningful, however, I agree to disagree.
    Onconasty is definity now "Not So Nasty". It's like in Dancing with Wolves, he has been re-named by his actions. There was a time.....:)

    But, as the PR states, they have been hired to assist in the conduct of this testing etc. and.....
    "In order for FDA to fully consider that next-stage clinical trial to evaluate LEAPS-H1N1 treatment of hospitalized patients with laboratory-confirmed H1N1 Pandemic Flu under an Exploratory IND, FDA has asked CEL-SCI to submit a detailed follow-up regulatory filing with extensive additional data. Thus, in parallel with ramping up its first study, CEL-SCI is proceeding on an expedited basis with the substantial undertaking necessary to complete this next submission. Recognizing that it cannot proceed with its next-stage clinical trial without the Agency's concurrence, CEL-SCI anticipates engaging in a detailed dialogue with FDA regarding the proposed LEAPS-H1N1 clinical-development program based upon this future filing".

    Cel Sci needs their assistance if for no other reason than they have a lot on their plate, all good stuff.

 
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