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PharmaCyte Biotech’s Investigational New Drug Application Placed on Hold by the U.S. FDA
LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer
About this update from Pharmacyte Biotech, Inc.
[{"type":"text","content":" LAGUNA HILLS, Calif.--(BUSINESS WIRE)--\nPharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that the company’s submitted Investigational New Drug application (IND) has been placed on hold. The notification gave no details as to the reason(s) for the FDA’s decision.\n\nThe FDA will issue an official hold letter within the next 30 days with written details identifying the reason(s) that FDA examiners issued the hold. Once PharmaCyte has the official letter it can address all of the identified reasons for the hold. Then, PharmaCyte will file a response to the official letter from the FDA. The FDA will have another 30 days to review the material submitted by PharmaCyte and decide whether to lift the hold.\n\nPharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “The decision by the FDA to place our IND application on hold was a deep disappointment to all of us at PharmaCyte; however, we are grateful that the FDA didn’t reject our IND application and we will have an opportunity to address their concerns. I know our many colleagues, who have worked so hard over the years to try to get our treatment ready for clinical use in patients with locally advanced inoperable pancreatic cancer in the hope that we can fulfill an unmet clinical need for such patients, are also disappointed, but we all welcome the opportunity to continue to engage with the FDA to further our treatment.\n\n“The disappoint also applies equally to our loyal and patient shareholders. We do not plan to give up in getting the hold lifted – we will do everything within our power to do so.”\n\nAbout PharmaCyte Biotech\n\nPharmaCyte Biotech, Inc. (PharmaCyte) is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed.\n\nPharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “c...