$SRPT I don't buy this. How much have they really learned in the past 2 yrs in regards to inclusion criteria? Honestly I think picking the right inclusion criteria is more difficult in larger disease populations where pts are more heterogenous. You said 18 months ago the issue was slow CMC scale up. Now it's they needed time to get the right incl criteria. Honestly they f$&ked up. If they believed the data from 6 pts was strong enough for acc approval, then trial design should have been easy. It's much harder to design a large phase 3 in "big" disease when you have a mixed ph 2 (works in subgroup) because hard to know how to enrich.
Gsk went broad . Usually you want to be more selective in phase 2 than 3. They did screw up, but that doesn't make SRPT screwup less obvious
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