You say "the FDA doesn't believe in the product." Huh?
Sorry you are disappointed, but you have to realise that we are literally waiting to hear any day (or week or month...) now from the OTAT on whether the potency assays are acceptable, right?
And if the answer is "Yes", that this would permit refiling of the BLA for Ryoncil, and likely approval of the same (where the CRL was only in respect of questions on the potency assays)?
And if that BLA is granted, then MSB will have the first ever FDA approval for an allogeneic stem cell treatment?
And it would then be able to instantly start selling stocks of Ryconcil in the US that is has manufactured and is manufacturing (where sales of the same product is increasing year on year in Japan)?
I won't bang on about CHF or CLBP, but the stories there are similar.
I don't see how you can expect a slow-moving tanker like the FDA to turn around quickly. They have to be convinced on ALL aspects of this product -- particularly where they are incredibly leery of the Disallowed salesmen pushing stem cells for EVERYTHING in the US which are totally out of control. They are trying to do this right, and set the bar sufficiently high to ensure they don't open the floodgates. Kids have suffered in the process, but clearly they see that outcome as the lesser of two evils.
It sounds to me like maybe you bought in on hype and perhaps didn't research the company, the state of the art in medicine--and in stem cells--and the politics surrounding the products as thoroughly as you should have. I have plenty of beefs with the company and SI, particularly their crappy comms and SI's perennially overpromising on deadlines, but I am pragmatic enough to recognise that what they are trying to do is NOT easy, and that they are on the cusp of finally cracking this nut.
Given all that, I am willing to give them (and OTAT) the benefit of the doubt, at least until we see what OTAT has to say and what guidance comes back on CHF (hopefully goosed a bit by a positive NEJM article...where is that thing?!). Of course the FDA could again pull the rug, knock back MSB's assays, indicate another 5-year trial is required for CHF, etc. But there are NO foregone conclusions here.
Information is power, mate - and it helps overcome fear and uncertainty.
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