No surprises here. Base case was always another P3 trial due to the small dataset <65. Manufacturing always had be sorted out before they approve a product, even for EUA.
Getting an EUA for a yet to be approved product was always in the hands of the FDA gods and no one should ever expect miracles from them.
Carry on. No change to status though good to see FDA have given preliminary tick of approval for potency assays. I believe we are on a firm path to approval for aGVHD minus another P3 which has not been mentioned for many months now. At a base case, that should fund the operating cost of the business.
Ann: MSB Annual Financial Results and Operational Progress, page-13
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