PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “CBER’s acceptance and processing of our Drug Master File without any questions or comments is a credit to the painstaking work and dedication by Austrianova and our consultants to ensuring that the entire process is properly conducted and completed before any further documents are submitted to the FDA.
“We now look forward to presenting the FDA with our Investigational New Drug Application very soon for our planned clinical trial in locally advanced, inoperable pancreatic cancer.”