1. They definitely have a shot at accelerated approval, but I’m still hesitant to says it’s a slam dunk because the FDA really surprised me this week. I said I would use this weekend to reassess and I’m still feeling a little uneasy about how the FDA will respond. In anyway case it’ll be a few more months at least until accelerated approval can be given... a new submission / process must kick off.
2. @Zenox posted an example of Sarepta... have a read of that.
im offline all day after this post, hope you all can enjoy a nice Spring day!
MSB to dispute FDA finding in Type A meeting, page-291
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