I agree, the other option would be to approve on a subset of the BLA. Grade 3 - 4 or MAP.
I been trying to understand why we are not treating on scale through compassion access or right to try frame works to gain more confirmation of the data we have.
Perhaps SI has been advised not too as this could give the FDA a way out of making a pivotal decision.
Insider bullish on MSB prior fda approval, page-78
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