You make some good points, rather worryingly. I would like to...

You make some good points, rather worryingly. I would like to add a couple of points also.



One is the value of the SPA, which is legally binding on the FDA. I must admit I don't have a great deal of experience with this, but my understanding is that the FDA set the endpoints and parameters of the trial and in all other respects were happy with the results. This certainly gives the impression that approval is a formality, which has been the market's understanding. This would add weight to your first scenario, that this is just a can kicking exercise to buy time, perhaps with the knowledge that a government shutdown was looming - the timing IS conspicuous after all. However, I understand that the SPA does not necessarily guarantee approval, only acceptance of the results, along with a few bonuses like a rolling nda and fast track etc. Perhaps somebody can correct me on this.



Two, even given the placebo affect, VivaGel is still a better alternative to the antibiotic treatments currently available, which have already received FDA approval. If you were a sufferer with bv and you wanted a treatment, wouldn't you prefer to use a non-antibiotic, easily applied solution with no side affects? At least the safety and tolerability of VivaGel is not in question, so that's got to count for something.



I must admit that I find the whole placebo affect fascinating - it tells us more about the human mind than anything. People in all sorts of trials often respond positively even when they KNOW they've had the placebo. It's the equivalent of visiting your doctor and coming away with a piece of paper - sometimes the act itself has a positive affect. So in VivaGels case, even if part of the efficacy is the simple act of doing something - the placebo affect - surely it would be better using a product which is non-antibiotic, safe and side affect free rather than take the current antibiotic options with known issues? Of course, that's not to say that the FDA will see it that way.



I must admit my biggest concern is that I smell a rat in all of this somewhere - I just don't know where the rat is lurking. It could be SPL, the FDA, some big pharma trying to protect its market share, another pharma priming an opportunistic takeover, or something else completely out of left field which we haven't considered yet. I really hope it's just a short time buying exercise. Only time will tell!