Just one thing: MSB have been working closely with FDA for years on trying to get approval on ryoncil: the primary endpoints agreed on, and met, yet only to be met by a "sorry we need an RCT in some form". Seems like FDA could have expressed this concern or advised MSB before commencing the phase 3 trial? this would be on FDA for not advising or guiding MSB properly on conducting a trial that would satisfy them? im not in the camp of the anti-Lizard People, but seems like negligence(?) or FDA finding an excuse to defer due dilligence on approval to manage their current workload: accusations aside and tldr: why was this need for a RCT a suprise?
MSB to dispute FDA finding in Type A meeting, page-368
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