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CatfishHunter

10/05/23 5:51 PM

#166814 RE: wrinklesobw #166813

He’s the Elmer FUD of this board lol. Shushhhh…he’s hunting wascally wabbits!

SC8

10/05/23 8:04 PM

#166819 RE: wrinklesobw #166813

Yes MK "will tell us everything that they choose to tel us in the quarterly update." That's a far cry from telling us everything.

MK entered into pre-sub program over two years and two offerings ago now. At no time has MK ever issued a clear path and timetable to IDE submission. He's wasted most of that time resisting FDA suggestions and pissing off scores of FDA reviewers.

Obviously he has nothing meaningful to say (aka a clear path and timetable) from FDA comments received and meeting last Friday to discuss those comments. It's also known as sitting on bad news, which MK has done before. All we know is, due to MK's ineptitude, Radiogel is now on the slow track at FDA