Force their hand is better than getting bad press from a subjective decision bought and paid for by those with influence. Only this year did FDA finally move to get big pharma influence reduced on ADCOM decisions. MHRA approved the SAP, they didn’t just accept it. That part of the application was already reviewed and approved which was the down payment on approval. Cart before the horse. They are now getting around to fixing the guidance so that they are prepared for and can defend what is coming not only from NWBO but also from others. Best wishes.
An SPA (special protocol assessment) is essentially just what I described. That can’t be given now but even then FDA can still renege albeit under tighter controls. Better to avoid stepping in the quicksand you see on the shortest route and take the longer way rather than hope you can get out afterwards; ). Best wishes.
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