PharmaCyte Biotech Inc (PMCB)

[DragonBear]

From the 10Q:

There's a couple of interesting ones.

·Demonstrate comparability between the 1st and 2nd generation products and ensure adequate and consistent product performance and safety between the two generations

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.

·Provide a discussion with data for the potential for cellular and humoral immune reactivity against the heterologous rat CYP2B1 protein and potential for induction of autoimmune-mediated tox

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?