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$PMCB 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.