Sure, but that is not what you said. The FDA approves the trial protocol and the DSMC should provide guidance during the trials.
But they are tasked with a limited mandate of (and I’m not saying this right because this isn’t my job nor training) making sure people aren’t dying inordinately, that there is no chance of success, or that success can be practically guaranteed at that snapshot in time.
I could be wrong here but I do not believe it would be on them to consider dosing (and if the drug didn’t work they would just call it and end it). I have questions about their performance in CD12, but at the same time this stuff was thrown together by a broke pre-revenue biotech during a pandemic meaning that the agility required simply may not have been there as it might be for a more traditional or larger biotech, which explains the opportunity.
No underdog can be beholden to more than giving their best effort considering the circumstances. There is a risk/reward analysis that anyone should consider. If CYDY had a more traditional path, there’d be less questions about its outcomes meaning I would have less chance to be rewarded exponentially by the way in which I have deployed my capital.
It’s healthy to remember all this controversy is due to the fact that this is a high risk high reward investment and one can’t enjoy the rewards of that risk without expecting reciprocation from the other half of that risk wager. Alpha is coming up on the winning side of that duality more often that not generally speaking, while specifically stated this investment has outperformance of expectations in spades.
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