"Priority Review"...When less is more.......I have to believe MCNA is a strong (potentially extremely strong) candidate to be eligible for a shortened (6 month) "Priority Review" period versus "Standard Review" period (10 months). ----- Given FDA definition below for "priority review" (and, see Beech's last post for safety and effectiveness comparatives) AND per Dr. Berendt's quote in press release... "therapies for bladder cancer patients who have NOT SEEN NEW THERAPIES approved for ALMOST 20 YEARS". ---- Upper case my insert. rg ---- Administrative Processing of Biologics License Application (BLA) Priority Review – a reduced review schedule compared to a standard review schedule to potentially allow the product to reach the market faster. Note: Products are eligible for priority review if they provide a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious or life-threatening disease. https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/ucm073074.htm ---- Dr. Michael Berendt, CEO & Chief Scientist of Telesta Therapeutics “There is an urgent and unmet medical need to develop new therapies for bladder cancer patients who have not seen new therapies approved for almost 20 years."