Surely everyone bagging out BSI understands that regulators exist to protect vulnerable populations from spending money (in this case possibly upwards of $15k a dose) on false hope that does nothing but lighten their bank balance.
With no RCT data and a very small sample size of an uncontrolled population, the clinical data would have to be amazing in every patient to get an approval. I think it's quite likely BSI have said they're happy to consider approval once powered RCT data or a hell of a lot more data of patients demonstrating good outcomes are provided to them. Either way, I think they're going to need a lot more $$$ and time.
Surely everyone bagging out BSI understands that regulators...
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