Will someone please post the list of required tests from the FDA to release the hold again?
They can't be posted, because Kenny never released the actual FDA letter.
There is just the Kenny list. Who knows what he has left out.
Definitely left out is Kenny stating: "The FDA accepted the Lohr data from 1999 to support a Phase 2b. And had no further questions or concerns about the data". SHs should try to get him to make that statement.
Instead Kenny is playing a charade. Implying some Kenny list of "tests" is all that needs to be done. So now he gets to recycle PR pumps of the past 4 yrs, about "tests" the next 2 yrs. After that shift down to a new Phase 1 IND, and pump that for a couple of yrs.