It very well might be. 2 years when they have real time data with compassionate care usage evidence is hard to believe. Probably why they chose smaller market (UK), to hammer out submission before going to FDA, among other reasons. JMO . And as lykiri has said, its frustrating. It appears the MHRA is walking them through exactly what they need to get it passed. But again, I have no evidence to back that up.
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