On October 2, 2020 PharmaCyte 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, reported 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 (Press release, PharmaCyte Biotech, OCT 2, 2020, View Source [SID1234567981]).
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The 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.
PharmaCyte’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.
"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."