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FeMike

06/29/23 9:35 AM

#605574 RE: Maverick0408 #605566

6) Rolling review already in the works. Approvals can come anytime.



We've absolutely seen this one before.

Prior to TLD, when investors were complaining that TLD was unnecessarily delayed by the slow JA and was holding up approvals, the rebut to that was that approvals were completely decoupled from TLD. That the company was probably already in rolling review (this is prior to May of '22) and that the approvals could come very soon after TLD because of that, or even before TLD.

People have been saying that we are in rolling review for well over a year. RR is supposed to speed up the process - that is not the case.

I don't know if we are in RR now or not. I hope so, but I wouldn't be shocked if we weren't. It is absolutely in expectation of NWBO that the next PR will simply announce, finally, that the application has been submitted to MHRA and the acceptance/review process is only just now finally starting. No Orbis, no FDA, no rolling review. Just plain old MAA submittal. And the reason is because LP has no idea what she is doing and the company execs are in way over their head.
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hoffmann6383

06/29/23 2:17 PM

#605667 RE: Maverick0408 #605566

NWBO stated 2023 submissions. Nothing has changed. There are no excuses. We only have the hedge fund social media army pushing false deadlines.
Bullish
Bullish