Potential for "Priority Review" revisited...With a few excerpts from white paper entitled, "Accelerating U.S. Regulatory Approval for Drugs and Biologics that Treat Serious Diseases" Link at bottom. "Priority Review" - Procedure: Upon receipt of application, clinical team leader of FDA review team makes recommendation. Division-specific decision; Criteria: Major advance in treatment or treatment where no adequate therapy exists; Benefit During Review: Expedited review (e.g., 4-6 months com-pared with 10-12 months). Link below. The consideration for Priority Review seems to be at the discretion of the FDA review team and there appears to be no formal application or request for this (not sure about latter part though). I would like to believe yesterday's announcement of Bioniche's Submission of Orphan Drug Designation Application for MCNA facilitates the above consideration. WRT Orphan Drug designation, per RetailRube's post, the definition provided also seems to be very much in sync with criteria needed for receiving "Priority Review". WRT "Fast Track Designation" according to same white paper, it does not appear to expedite the final "marketing application review" period. Key benefit appears to be primarily "more frequent FDA communication" per paper. However, the criteria for receiving FT designation.... Serious or life-threatening condition and Potential to address unmet medical need....again, seem to tie back or be quite in sync with criteria for receiving "Priority Review". Link to white paper with above excerpts (previously posted): https://resources.rhoworld.com/Portals/161293/docs/Accelerated_Approvals_FINAL.pdf I also found the link Biochamp provided to be easy-to-understand and succinct: repost of link: https://www.focr.org/priority-review