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07/26/23 11:04 PM

#163354 RE: wrinklesobw #163353

All facts. Nothing left out. MK said on May 24, 2021 he needed another 90-120 days to submit IDE application. Fact. Unlike his prior missed forecast he retracted with that May 24, 2021 statement, he never retracted that 90-120 day forecast. Fact. 120 days after May 24, 2021 is Sept 21, 2021. Fact.

One could go on and mention the fact MK pulled a bait and switch on Sept. 20, 2021 by announcing he only submitted a draft IDE application and was entering into pre-submission discussions with FDA, but that doesn't change any of the facts and actually puts MK in a worse light by revealing only a day before his submission forecast window closing he wasn't even close to being ready to submit an actual IDE application for Radiogel human trials. Fact.

And here we are getting on two years later with no end in sight, no clear path forward, no timetable and uncertain cash situation. Yet MK is still wasting time peddling money losing IsoPet at expense of getting FDA what they need to consider Radiogel for human trials. All facts.