PharmaCyte Biotech Inc (PMCB)

[rudygerner]

"Other highly positive news provided by Mr. Waggoner concerning the pre-IND meeting with the FDA included:

- agreement with the FDA that PharmaCyte is on the “right track” in its development program;

- agreement with the FDA on the cell line that will be used in the clinical trial;

- agreement with the FDA on the patient population to be studied in the clinical trial;

- agreement with the FDA on the secondary endpoints of the clinical trial, except that PFS will be added to the list of secondary endpoints if the trial becomes a pivotal trial;

- agreement with the FDA on the number of patients needed to comprise an adequate safety database for a Biologics Licensing Application for CypCaps™;

- agreement that the FDA believes CypCaps™ is a drug/device combination product;

- agreement with the FDA that it will assist PharmaCyte in its development program; and

-agreement with the FDA that the next step for PharmaCyte is to submit an IND."

http://ir.pharmacytebiotech.com/press-releases/detail/133/pharmacyte-biotech-moves-closer-to-filing-ind-with-naming