PMCB - FDA places hold on PharmaCyte's cell therapy IND for pancreatic cancer
OTC listed PharmaCyte Biotech sinks ([[PMCB]] -49.2%) after the FDA placed a hold on the company's Investigational New Drug ((IND)) application for a planned Phase 2b trial in locally advanced, inoperable pancreatic cancer. Details on the reason(s) were not disclosed.PharmaCyte’s therapy based on live-cell encapsulation technology involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form.The FDA will issue an official hold letter within the next 30 days with written details identifying the reason(s). PharmaCyte will file a response addressing all of the identified reasons for the hold. The FDA will have another 30 days to review and decide whether to lift the hold.
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FDA places hold on PharmaCyte's cell therapy IND for pancreatic cancer