Yes the negotiations with the FDA are somewhat elastic because...

Yes the negotiations with the FDA are somewhat elastic because these are ground breaking clinical trials and the nature of stem cells is being recognised as separate and distinct to the extremely restrictive protocols which apply to pharmaceutical drugs. These are the first FDA clinical trials involving stem cells which have got to this stage of safety and efficacy.

The prospect of the FDA reviewing protocols and fast tracking anticipated by posters such as myself was openly and loudly derided by some who claimed that the FDA would continue to apply the pharmaceutical drug protocols, (clearly a ridiculous position which offends logic and later, fact). Despite the FDA clearly stating to the contrary, such posters continued to argue delay and high costs as if the high risk pharmaceutical model were to continue to be applied.

It is telling that such posters are thin on the ground these days after expending vast amounts of energy arguing against what simple logic would demand. Job done I guess.

And yes, I think logic and expediency is going to win with the FDA here. After all, why should they put road blocks in the way if overwhelming efficacy is demonstrated? The savings involved and human benefits are substantial and that's putting it very mildly indeed. That the FDA are developing the protocols as they go, and Teva has been extremely effective in negotiations, and can be expected to continue to do this, seems obvious.