Interesting workaround to the RCT requirement, but the FDA have held steadfast to their requirement and the ODAC recommendation to conduct a RCT trial in Adults. The good news is if the trial is successful in high-risk Adults then MSB is almost guaranteed to get approval, and for a much larger population as well, and could potentially also command a very, very high price for their treatment. MSB now need to bite the bullet and conduct this RCT.
A more important question now is what will the FDA consider to be the appropriate control group, a historical control perhaps? They didn't accept MSB's calculation for the historical control group for the pediatric cohort, so............
Interesting workaround to the RCT requirement, but the FDA have...
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