Delay disappointing. Perspective helpful...If I understand correctly, Telesta has been working closely with the FDA re preparedness of the upcoming MCNA BLA filing on 2 fronts: 1) the filing submission relating to proper presentation of existing MCNA trial data for potential FDA approval of the treatment itself (as its defined), and 2) the preparation for the actual FDA manufacturing audit. --- The first, the approval of the $ecret $auce, MCNA, represents the majority of the future value of Telesta. The second, to actually manufacture MCNA at Telesta's Montreal manufacturing plant, an important bonus. MCNA could probably be manufactured at a hosts of existing pharma manufacturing plants. --- Bottomline, the timing delay is fundamentally related to the second point, which just happens to affect the "timing" (and, only the timing), of the critical first point. --- Also, do you think the FDA might now be more sensitive to the manufacturing process and plant for MCNA production following the serious shortage of BCG due to manufacturing problems at the two major BCG producers (Merck and Sanofi Pasteur) in 2014 and into2015?? See links --- Jan. 21-15 --- https://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=915 --- https://www.theglobeandmail.com/life/health-and-fitness/health/shortage-of-vital-bladder-cancer-drug-prompts-rationing/article20464929/ --- And, of course, the rest of the press release was positive. ---- As the British would repeat again.... "Keep calm and carry on"... We will win this war. Enjoy the wk-end! rg