A normal PDUFA date would be a year from when a biotech submits the BLA. That encompasses the 2 months the FDA has to accept or reject the application for review and 10m to review it. A Priority Review would be 4 months shorter (8m). If they get a Breakthrough Therapy designation, they would get an expediated review and try to shorten the Priority Review by a month (7ish months). If they are going for Orbit and/or RTOR you would expect them to get BTD first, at least that's how I see it playing out with other drug companies.
I could be wrong but I believe the potential impact of this news has regulators actually working with NWBO about suggested timing of the journal article if not directly the indirectly. Best wishes.
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