Friday, April 02, 2021 11:27:23 AM
Yesterday I outlined how Kenny produced PR pumps for cell stability testing at 3 months, 6 months, 12 months, with it to run 24 months. I missed the 10Q mention for 9 months. Kenny can crank out another 4 PR pumps about "cell stability" in the coming year. Then in Oct-Nov 2022, Kenny has to ask the FDA if it's ok to keep going to a 3 yr stability test for shelf life. Unclear if that will be an issue or not. If the FDA only allows a shelf life of 2 yrs, then they have to re-manufacture new lots to fit the 2 yr time frame. Because there's no way in hell there will be any Phase 2b IND approved before 2022, or even after.
And it's still "totally meaningless".
The phase 2b IND, skipping Phase 1-2a was based on faulty ad hoc Lohr studies from 1999. You just can't time travel back to 1999 to fix the faults. Instead Kenny would have to start over with a Phase 1. Pending acceptable IND test results.
Kenny is a master at crafting PR pumps with plausible deniability.
The Jewel of the Mind is Colored with the Hue of what it Imagines
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