Can those of us who think it is now far more likely than not that an approval is imminent (I am in that camp and have bought more shares as recently as this morning), now please absent the personal attacks look at what the most likely basis for another knock back might be? I'm really hoping this discussion is more science than name calling. The preponderance of arguments presented here, (largely factual) in my humble opinion clearly favour an approval. In hindsight, the FDA whilst acting contrary to the advice of the solid majority of experts did nevertheless request answers to questions that were obviously not adequately addressed first time around. The CRL issued to most of our dismay, but it now seems MSB put their heads down and has resubmitted with fresh material that no matter how you argue it, was sufficient to justify a further review (I am deliberately not using the correct terminology and relying on analogous terms so everyone might digest this for what it is). That review commenced and following a clear and systematic pathway toward deciding the fate of the application, the FDA obviously reached a point where a look under the manufacturing hood was also warranted. We have all read and digested that this in itself was a significant step suggesting we were still well and truly in the game. We then all observed the vascilating positions and debate that followed and ultimately were informed irrefutably that there was nothing detected by four inspectors that was of such concern a formal "defects type notice" must issue. That was very significant, because on my understanding whilst we might yet see the likes of the equivalent of a minor infringement notice with regards manufacturing, we can essentially put to bed any concerns that issue is going to feature on any new list of possible reasons we are denied an approval, to such an extent we are forever doomed. I appreciate we don't actually know yet what the decision is regarding whether the additional information has "adequately" addressed the specific concerns raised in the CRL to begin with, but there appears to be at least some surrounding information that contradicts the likelihood the FDA are working up another refusal and it appears fair to conclude, prima facie, the resubmission addressed concerns or there would have been four less tickets to Singapore on the FDA's tab. The Japan factor is ostensibly irrelevant from the approval process, but it has always given me comfort that whatever iteration of the cells used in Japan are, they nevertheless work. Of course we have other pieces of the jigsaw and some of our more learned pro MSB posters, I at least believe, present arguments so compelling when considered alongside the contrarian position, absolutely substantiate the view this "biotechnology" is now very very close to becoming mainstream treatment for Pediatric aGVHD, but also for various other conditions with label extensions and in its different forms. I too am of the view the announcement concerning the appointment of an ex Deputy Director of the FDA, is not something one can brush over. Coincidences certainly occur, but the timing at least peaks ones curiosity. I guess you could argue MSB is backing its own horse along with the appointment of fifteen new staff to roll out the product and they certainly have stockpiled a rather tidy amount of horse food in preparation for the big race and beyond. So to come back then to my original question, if one were firmly of the view the ducks are lined up this time around, surely the only real concern is the absence of the RCT which I appreciate on ethical grounds would just plain stink. But is that it if we operate on the premise for this debate the FDA are satisfied on all other fronts, because then absent any new concern, that is the only thing we haven't done isn't it? On another note surely these are the cheapest front row seats you will ever get if we finally get what we mostly seem to agree is looking like an approval. In fact once bitten twice shy and likely the irrational part of me is troubled by the low share price. I am grateful to still be buying at close to one dollar, but just a little confounded as to why this story hasn't caught on. Isn't this now at the point where you are getting to back the favourite at long odds?
Expand
(20min delay)