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HyGro

12/30/25 12:40 AM

#805372 RE: SkyLimit2022 #805370

Getting conned by the CEO -- If you only have the cash to do ONE filing, you do the FDA as the return is much more substantial. But FDA wouldn't accept their application so they didn't have the choice. Getting approved in UK is not going to improve the odds in the U.S. FDA doesn't rely on other regulators, other regulators rely on FDA.
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HyGro

12/30/25 2:31 AM

#805378 RE: SkyLimit2022 #805370

Ridiculous -- MHRA approval has no bearing on the U.S. decision. If they couldn't afford a U.S. filing, but still had the money to file in UK -- ridiculous. NWBO can't survive on UK business as it will take years and more trials to get full NICE acceptance -- just like Gilead's CAR-T that took 5 years and multiple more trials to get NICE acceptance and beyond the NICE charity that only paid for ~100 patients a year at greatly reduced pricing.

FDA is not going to accept the P3 trial and NWBO certainly doesn't have the money or time to run another P3 trial that took a decade the way they run trials.
This is a company burning shareholder cash through vulture funds, who dilute the hell out of shareholders.

What a con job.