The 1st generation "product" is what Lohr used in 1999. It was found subsequently to be unstable in enzyme production. How does one demonstrate "comparability"? Unless the current generation is likewise unstable in enzyme production.
Yet another problem in attempting to use the Lohr ad hoc studies to skip Phase 1-2a.
Another 1-2 yr test. Mimic the time the CIABs would be in the human body.
At no point has Kenny ever told SHs, the FDA accepted the Lohr ad hoc studies as a basis for a Phase 2b. With no additional concerns or questions. Now what would be the harm in Kenny issuing a PR pump stating exactly that?