Saturday, August 03, 2019 4:57:11 PM
[quoteBetween August and November would be my guess, as I'd think it would depend upon the RA reactions to the "draft"][/quote]
That means that they will or have already sent the SAP draft to the FDA and based on the FDA's suggestions, NWBO will clean up and finalize the draft.
Thanks for your input because I was under the impression that NWBO had not only the task of completing the draft but also had to upgrade the draft to their (NWBO's) final version before sending it for review to the FDA.
I am guessing that you believe that the draft had already been sent to the FDA and it is currently being reviewed. I wonder if we are only a few months away from finalization of the draft and approval (or disapproval)?
That means that they will or have already sent the SAP draft to the FDA and based on the FDA's suggestions, NWBO will clean up and finalize the draft.
Thanks for your input because I was under the impression that NWBO had not only the task of completing the draft but also had to upgrade the draft to their (NWBO's) final version before sending it for review to the FDA.
I am guessing that you believe that the draft had already been sent to the FDA and it is currently being reviewed. I wonder if we are only a few months away from finalization of the draft and approval (or disapproval)?
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