i agree, i don't think the FDA is in the clear as far as being on wrong side. they absolutely could have done better and I don't know why they even wrote the letter at all. I am sure the FDA has an endless amount of hate mail, social media criticism , etc.. they should be well able to ignore it and stay in their lane. They know how difficult it is to get a drug through trials, otherwise why would they invent all these special programs for drugs to circumvent their own process. all drugs should be treated as if they are BTD and orphan drugs.

as for the DSMC, i think they are appointed by the sponsor and I don't think the FDA has much to do with that. I have no idea why they are not given the power to look closer at the trial and why they did not see the problems, it could be when they looked, everything was good. after that is when we really started pushing to get fully enrolled and that might have been when the wrong patient skew took place. Again, this was an Amarex screw up because Cytodyn started sending our employee out to help with recruitment when that was Amarex's job. We were also competing with every other drug trial going on. Stopping compassionate use was part of this, if patient had the choice of life saving drug from compassionate use or possibly getting placebo, they chose compassionate use. Closing this was an attempt to get the trial enrolled.