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skitahoe

06/20/25 8:42 PM

#772362 RE: manibiotech #772361

Mani, I agree, but in reality, I don't believe management has provided any indication they're doing something, like the agreement with Roswell, then suddenly it's happened.

The one time they announced something prematurely it was an intent to file for approval with the UK, and then they had to revise their timing a couple times. No company I've ever followed has predicted when a regulator would act. If it was the FDA, a PDUFA date was set, but no statement until the FDA did something official.

Frankly NWBO has less control than many because they rely on contractors for so much that they do. I'm guessing that if they receive a RFI that a contractor will be involved in the answer, and perhaps be largely responsible for it. Most companies are bigger and while contractors might be involved, they'd have the lead, I don't think it's necessarily the case with NWBO though they certainly play a part.

It's impossible to say if everything is in the hands of the regulators today, or if NWBO still owes them information before they can proceed further. Once the regulator is satisfied, they'll make a decision, if not, they may ask additional questions and no telling how much more time will be added. Hopefully there are no more questions.

Gary