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    In order for FDA to fully consider a 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. "We are pleased that such a prestigious medical center has given clearance to proceed with this first study of our LEAPS-H1N1 treatment ... Given the nature and severity of the virus, we are working diligently with our CRO and Johns Hopkins, and actively preparing submissions to the FDA, to support the fastest and most effective way to conduct clinical trials going forward for this unique investigational treatment." The initiation of CEL-SCI's rapidly-accelerated LEAPS-H1N1 clinical development program builds on CEL-SCI's pioneering work with its LEAPS technology in the context of H1N1. Full Article at Medical News Today
    We are pleased that such a prestigious medical center has given clearance to proceed with this first study of our LEAPS-H1N1 treatment ... Given the nature and severity of the virus, we are working diligently with our CRO and Johns Hopkins, and actively preparing submissions to the FDA, to support the fastest and most effective way to conduct clinical trials going forward for this unique investigational treatment.
    SOURCE: Medical News Today 3 weeks ago