Not having your expertise, I sense you are on point.
Covid has exposed corruption between the FDA and big pharma for what it is. I believe that stem cells and AI are the big movers in the next decade. This is an opportunity for the FDA to get leg up of big pharma and provide them with ultimate leverage. As such i suspect approval in August a slam dunk.
Ann: MSB Reports Q3 Financial Results and Operational Highlights, page-327
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