InvestorsHub Logo
Followers 1
Posts 433
Boards Moderated 0
Alias Born 12/21/2017

Re: FIREST1 post# 96344

Sunday, 07/01/2018 12:23:34 AM

Sunday, July 01, 2018 12:23:34 AM

Post# of 106837
No, not an issue with the FDA. This is about someone without the proper medical/clinical trial training running sham studies to trick patients into believing they are participating in a legitimate clinical trials being properly reviewed and adhering to Good Clinical Practices (GCP) and in partnership with the regulatory authority for the United States (the FDA). Ask any regulatory specialist how to manage an FDA inspection and how to respond to 483s and FDA warning letters. That’s not even close to a proper response. It’s embarrassing and Shameful, showing not one ounce of respect for this important safety net to protect patients.