Hi @patientvalue you have added some conjecture and its fair to do so. With treatments that are approved for use against illness it is imperative that each patient recieves the correct and effective dosing. If there is a cloud over varying "potency" with Ryoncil both the patient suffering and the person footing the bill are being somewhat shortchanged? How can you ensure that all doses all equal, that all doses have the same effectiveness - very valid concerns. I think the ODAC where walked thru by SI/FG to outline the stem cell chain product but not entirely convinced. The FDA did not have the company present to do the same scenario, the FDA acts independently of the ODAC and their valued input while reviewed is non binding, so having another meeting may be just noise unless they [MSB] can pull a rabbit out of the hat and prove beyond doubt that all produced doses of Ryoncil will be exact and precise equal to each other. Somehow it seems another trial which is placebo controlled to prove/disprove efficacy would be kinda unethical...I mean who gets to chose? The parents? The doctors? Not the kids under 12yrs old......thats a tough one. Even in adults facing death be they 20/30/70 yo its a very difficult call to make. Today we came face to face with the realisation that after all theres years of study/trials and money, 1 date can make all the difference to a companies future. Just "wow" To all those who chose to derisk prior to the TH, well done you. To all those listening to others saying don't sell your stock cheap to the big boys, well hey they are alot cheaper now. To all those investors looking at the long game, we have hit quite a major hurdle/sticking point in the quest to have disruptive cell based therapy as an off the shelf treatment, but the game is far from over. OK we scored an own goal today for sure, I was somewhat disappointed that the "gloss" of including Joanne Kurtzbergs comments to back up outcomes in the release....only because it means nada to the FDA issue of the CRL, they have stated want they want. It didn't include another meeting, it didn't include any opinions from the ODAC commitee. It included that they need more proof and another trial is what they want. If the company can convince them to do it post approval, there is a new pardigm, remembering its a first in class treatment that they will run the most powerful microscope over they can find. Anyways we have the decision and its not favorable to MSB and their product pipeline, but again they will not go away and sulk, they will continue treating illness with science that the FDA may have trouble in comprehending. It is up to MSB to educate us all inclusive as to the benefis to mankind and medicine of "MSC's" they are the world leader. Bring on the ARDS 45% readouts and port haste on those CHF/CLBP trials data, lets flood em with proof across the board. OK vented.....GLTAH and try to enjoy you weekend, I had to change sentiment because I'm still somewhat perplexed although the tiny needle of delay did point me to a no result game....for now. chrs.
(20min delay)