Replies to post #38103 on Cel Sci Corporation (CVM)

[fluteman]

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[Biobonic]

Submitting to the FDA

This post will be totally and completely my viewpoint.

I have no links to back up what I think.

Either way, whether with supportive links or not, my thinking may be totally off base.

IMO - Geert was showing the FDA respect by submitting before announcing.

(A good thing when one considers the 2016 - "I'm going to add some more patients to the trail" fiasco.)

IMO - The FDA has no mechanism to 'accept' the CSR without a Marketing Application. (BLA in CVM's situation)

IMO - Therefore the FDA will not receive it prior.


Again - In my opinion.