Cel Sci Corporation (CVM)

[morecheese]

But the letter says the FDA is not lifting the hold due to the study being complete as per the below in quotes.

The part that confuses me is where the FDA states they found something new that they don't like, which isn't specified in the letter. But CVM is saying, from what I see, that this doesn't matter unless they needed to plan more studies. And if so they will amend then, which hopefully they won't.

What is your take on that part of the letter?


"In the Agency’s May 2017, letter, the FDA stated, “Finally, since there are no patients currently receiving Multikine under this IND and the only study being conducted under this IND (Study CA001P3) is closed to accrual, we have concluded that all studies covered by this IND must be placed on clinical hold; proposed studies may not be initiated, and ongoing studies are suspended.” It should be noted that, at present, CEL-SCI is not conducting other studies with Multikine under this IND other than the ongoing Phase 3 study which is subject to the clinical hold, no other studies are planned in the immediate future, and an amendment to the Phase 3 head and neck cancer study will be filed only if required"