CYDY *accepting* the dosing given by the FDA is not the same thing as them *agreeing* with it. We all know how it works. The FDA has to approve the trial. If the FDA says “two doses” and they are determined not to budge from that, then the company has no choice but to accept two doses if they want the trial approved.
Go back and read the transcript from the conference call. It’s pretty obvious what Dr. Jay was saying. They wanted 4 doses. The FDA said 2. During the interim review, Dr. Jay was still concerned about the dosing, so he asked them to see if the data to that point was showing a need to change the dosage. DSMB said nope, nothing to see here. Keep going with the initial plan.
As Rockleo pointed out, the interim data DID support a change in dosage.