"FDA has asked CEL-SCI to submit a detailed follow-up regulatory filing with extensive additional data."
"This followed the very responsive and expedited initial review of CEL-SCI's regulatory submission for this study proposal. Following completion of manufacturing, initiation of this first study is subject to IRB review and approval."
"...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..."
They haven't had a discussion yet?!?
"...Moving forward, we also appreciate FDA's willingness to consider..."
The FDA didn't throw it back in your face. That's a start...
"As we prepare to initiate our first study... [we expect to] develop[e] the necessary data and appropriate protocols to ensure that we rigorously meet the FDA regulatory requirements..."
And this hasn't been done already because?!?
"...given how much time and attention the expert scientists at FDA are directing to Pandemic Flu amidst all the other demands placed on the Agency in the course of fulfilling its critical public health mission."
The FDA has already approved SEVERAL well established companies to produce the vaccine, and clinical trials have ALREADY been run, showing it effective.
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