I DON’T KNOW, but my thoughts are that when MSB initially went to the FDA for an avenue to test/trial their therapy, MSB wasn’t seeking approval to treat 12 patients for proof that MSB’s therapy works but rather something more like up to 50.
Further; when the treatment of first 12 patients of the EAP yielded such exceedingly good results it was compelling (due to economics and urgency) to dispense with the EAP and to immediately enter into a more expansive formal FDA trial which carried more legitimacy. (Given the great early EAP trial success I find it difficult to accept that access to the treatment would be denied to those super critical patients that remained prior to the start of the official trial).
Further again; In the official trial, it’s now almost 2 weeks since the initial dosing. If the trial is following the EAP script there should now be a number of patients doing exceedingly well and almost an equal number struggling on ventilators with conditions perhaps deteriorating. Dilemma; intervention by trial administrators for placebo dosed patients with critical vitals.
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