MSB to dispute FDA finding in Type A meeting, page-194

I got a reply to my FDA email. I left out the womans name..


Dear Consumer: Thank you for your email to the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) about Mesoblast. One of seven centers within FDA, CBER is responsible for the regulation of many biologically-derived products including blood intended for transfusion, blood components and derivatives, vaccines, allergenic extracts, and cell, tissue and gene therapy products. As a general matter, the FDA is prohibited by regulation and statute from acknowledging the existence of an Investigational New Drug Application (IND), or if its existence is known, disclosing any information that may be contained in such application (see 21 Code of Federal Regulations (CFR) Part601.50, 601.51 and 312.130). You may want to contact the sponsor/developer of the product that you are referring to directly to obtain information about the development of their product. Information on the Oncologic Drugs Advisory Committee is available on the FDA website athttps://www.fda.gov/advisory-committees/human-drug-advisory-committees/oncologic-drugs-advisory-committee . We hope this information is helpful. If you have questions, please feel free to contact us by email [email protected] or by phone at 1-800-835-4709. Sincerely,