I think you hit the nail on the head.
I believe the mention of the word “conditional” by SI is very telling. He has never, to my knowledge, mentioned that word before when discussing approval. it has always been “full approval” in children under 12. They have always offered to conduct a confirmatory P4 trial in adults with full approval.
Could it be that the guidance offered by the FDA during the ongoing discussions since the CRL was to get the potency assays and MOA agreed and a conditional approval will be given whereby a confirmatory P4 trial will be conducted in adults? With the additional data to be given to the FDA on survival outcomes being so strong adding support to this likely outcome.
Pure conjecture I know, but sits well with me and would be the ideal outcome that satisfies all concerned, the patients, the company and the FDA.
I think you hit the nail on the head.I believe the mention of...
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