nice article by Jason N. He is being conservative (I would contend) assigning a 25% approval likelihood prediction, to be sure. He wrote and basically assigned this percentage merely by reviewing the eventual approval status of all previous applicants who at one point achieved or were approved by the FDA for NVIV's currently assigned regulatory track. I would contend that using this classification is, if anything, a suggestion of the very strong chance the scaffold gets approved. As an analyst, he is understandably grasping for any benchmark to show that there is definite caution in any FDA related application.
As regards the 25% figure, the truth is who knows what these early approval exceptions were for, what they proposed to do, cure, or address, or how many years ago the data for this regulatory classification was maintained, and under what circumstances, i.e. have their been modifications one way or the other, to the classification, from a regulatory standpoint ( going back a decade or more perhaps, if such data has been even kept). For that matter, while I do not doubt him, I wonder how he got the data on this sort of approval percentage rate, who maintains the data, and is it for drug applicants as well, as opposed to a medical device, which is more of what NVIV has going for it. The eventual non approvals could have been for literally, a hundred different reasons, none of which may have the slightest connection to what NVIV is doing. I think "slotting" our scaffold with perhaps hundreds of other applicants, going back who knows how many years, addressing perhaps different medical topics, has little value. It is enough for all investors to know that many of the applicants in the same approval track as NVIV, have not gained eventual FDA full approval, and have in fact been denied approval. That being said, the monkey and now human data for the scaffold has been essentially 100$ consistent as showing a safe, material improvement in the condition of the subjects. I think how this measures up to the regulatory test of probably helpful, (not the exact test language), it would appear that NVIV looks to be in very good shape indeed. The only thing I can think is that in preclincials and now with the Fab Five subjects, a skeptic would say something ridiculous like they showed unintended selection bias with monkeys by not having them present the way the eventual human subject pool will present, medically speaking; ie. the injuries to the monkeys were not severe, and that they are cherry picking sci human victims. But man, I cannot imagine this being remotely credible and it sure seems like Jessie's injury was biologically catastrophic indeed. (not saying Jason's was not horrifying as well).
