Tuesday, June 27, 2017 10:28:20 AM
Question: In the release on 4/8/2016 it was stated that there was a positive opinion from the Thai FDA. However there was no mention oF cGMP certification. Does the positive opinion mean this, and does PMCB still need cGMP certification from the U.S. FDA?
Response:Thank you for your email and for your interest in PharmaCyte Biotech. The Thai FDA does not have anything to do with the GMP approval or the U.S. FDA. This news is key to PharmaCyte because it now means that the facility can manufacture our product in Thailand. The facility had to be inspected and approved by the Thai government before any product could be manufactured or shipped by Austrianova.
With this approval now in place, it will essentially act as a precursor to GMP compliance for the production of the Cell in a Box capsules for our pancreatic cancer therapy. We expect the facility to be GMP-compliant for this process very soon now.
Thanks again for your email and interest in PharmaCyte.
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