Assessing the full ramifications of collected data does not equal manipulating data. Low risk patients are always inherent in any treatment protocol. Distinguishing & expansively accounting for the precise microcellular environment conditions responsible for positive & negative responses are of paramount interest to the FDA, NIH, & their global equivalents because complete data valuably contributes to all treatments & future cancer research.
As such, it is already a foregone conclusion that the BLA will be approved. Whether PDUFA is granted to cel-sci for the "It-Matters" study or not does not foreclose, future approval of Multikine as long as it is an incontrovertibly effective treatment option for non-trivial portion of, at present, squamous cell sarcoma paitents
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