As Dew has stated ATryn does not meet the fast track requirements as there is an alternative drug.
That is for humanitarian reasons due to the absence of any treatment, although the alternative is very very expensive and sepsis dangerous. Still, there is an alternative.
An argument would need to be made that the possibility of sepsis makes ATryn meet the humanitarian condition. That would need to be submitted as a rule exception, in some way.
Has this kind of exception been made, is this realistic?
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