Thanks Denisk. Based on the requirements, it seems to me that most of that could easily be ready beforehand. The only catch I can see it that the application must be submitted through some new electronic system, and my question there would be if it is a system where much of it can be done electronically, saved, and completed later? You would think with people in Congress pushing for the Kidney Patient Act (I think it has new name) UNCY could find someone to cut through the red tape to advance this whole process (including the FDA approval) a little quicker in order to help patients, but assume that would involve "contributing" to some scheme.
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