Well I asked you not long back to come up with a trial for children. You went quite, dont no why? I also asked about the Magic Concortium biomarkers , should they be used? So how about you put forward something that would meet your standards.
I am of the opinion that a trial today would be very different to one that would have been commenced after the CRL. Thankfully SI new what the results would have been. They would have come up with the same result and not adress any of the FDAs concerns.
MAB data has the potential to cut the trial length from years to weeks. But why would the FDA ask for a trial?
Perhaps they see to many compounding factors or to much post hock annalases. But then why not just rellie on a registar. Same input same outcome and it would be out there for all to see.
2023 The Final Countdown, page-2709
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