That was before the start of the Trial when no one knew for sure what was facing the world....during the course of it the DSMB reviews the data and in consultation with the sponsor a recommendation could have been made to increase the doses if it was viable. Was that done and the FDA denied it?...I call BS!
I reiterate again....the FDA does not run Trials nor is it responsible for unilaterally making decisions about how a company's trial is conducted. How stupid is that theory...........
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