I hope this RPM is not involved in the decision ma
Post# of 148155
Quote:
I hope this RPM is not involved in the decision making process to lift the hold.
The RPM is the point person between the company and the rest of the FDA. They also manage the entire team reviewing the drug, which would include a clinical hold. They wouldn't be the sole person to initiate a clinical hold but would be involved in the decision making process.
After the potential bias shown in Strayhorn's testimony the FDA should recuse her from any dealings with Cytodyn. Bureaucracy being what it is the FDA probably doesn't care. On the plus side the clinicians, scientists and statisticians are going to base their recommendations on the evidence. If an RPM goes against their advice there might be hell to pay.