brazen22,
The rules for label extensions as regarding this discussion are found in Subpart D-FDA action on Submissions, Requests and Applications starting with “99.301 Agency action on a submission”. I still have not found the individual case that I saw with regard to this but again, this is part of a group of exceptions that I am sure NWBO has been working under including the exceptions pathway to adequate and well controlled studies which I mentioned near the beginning g if my posting history on ihub. MHRA has a similar setup but I have not looked through that yet as I wanted first to confirm that this exception pathway with FDA is available.
I’ll look into the rest later just for you unless someone else wants to check it out first before me; ). Best wishes.
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