PharmaCyte Biotech Inc (PMCB)

[pennyvestor]

PharmaCyte Biotech Continues to Engage the FDA During 30-Day Comment Period

September 23, 2020
LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical-stage 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 continues to engage with the U.S. Food and Drug Administration (FDA) during its 30-day comment period regarding the company’s submitted Investigational New Drug application (IND).

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the interactions with the FDA, “We anticipated a number of engagements with the FDA to supplement key information related to our complex treatment. We are advancing a biologic, which is far more complex than developing a single-molecule drug. To our knowledge, the FDA has never had to assess a live-cell encapsulation technology such as ours. The FDA is fully engaged as it assesses the need for our product candidate to be safe and to comply with every cGMP regulation and FDA guidance.

“So far, we have had 5 opportunities to answer the FDA’s questions by supplying the regulatory agency with further clarification and supporting documentation, and we’re pleased with the process to date.”

Once PharmaCyte (the sponsor) submitted its IND, the sponsor must wait 30 calendar days before initiating any clinical trial. During this time, the FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: https://www.PharmaCyte.com/Cancer

https://ir.pharmacyte.com/press-releases/detail/256