Full disclosure would have been an indication all along from the FDA (in the spirit of collegial relations) that they would still require a new RCT no matter what additional RWD MSB could come up with and that MSB couldn't start that until the potency assay was signed off.
If that news had been passed on then we wouldn't be in this mess. The whole approval process is a shemozzle.
FDA could approve it for the children, page-6
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