I am sure this has been well covered by many imminent posters and I suggest you reread all OP’s posts.
In short
Where you have orphan conditions such as srGvHD then FDA have allowed a single arm study as the case here. This was done in consultation with the management at the time at the FDA. Change of management decided to revert to standard practice phase 3 randomised trial, ignoring precedent, agreed action, expert advice and an unmet need.
As for the reason? Can you reason the unreasonable? There are no alternatives for these Kids, therefore those who may have had our therapy will now die. It is the grounds for the appeal.
regards
Yelrom
USD573M in retained losses and a less than great 2020!. 2021 a year that cannot get worse, page-264
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