Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-65

"PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted 6 months to review the drug. These time frames begin on the date that an NDA is accepted by the FDA as complete."

In other words, that is the time (6 months) that is dictated by the act.

My expection is that it will be quicker, as per the previous annoncement of 9 July 2 Months (Mesoblast expectation and possibly advice given by FDA) - 6 months (maximum required by the act).