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Tuesday, May 11, 2021 2:27:07 PM
PMCB has successfully completed the twelve-months product stability testing required by the U.S. Food and Drug Administration (FDA) for its CypCaps™ final clinical trial product. This product will be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer upon the FDA lifting the clinical hold on PharmaCyte’s Investigational New Drug Application (IND).
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner , said of the completed twelve-month stability study, “We are pleased that our CypCaps™ product successfully completed all of the required stability tests and that the product has now shown itself to be stable and active after being stored for 1 year at -80oC. The study will continue in order to determine the maximum shelf life of the CypCaps™ product. It should be noted that this data is exceptional for a product of this kind.”
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