Just a shout out to the lawyers here - MSB will be VERY well represented by advisors/lawyers that know the inner workings of the FDA like the back of their hands (likely ex-FDA lawyers themselves) and will be there at the meetings with SI and Dr Fred to press the case. No time to skimp on consultants fees - bring out the big, well-connected guns.
MSB to dispute FDA finding in Type A meeting, page-173
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