Ann: Fast Track Access To Potential Japan Investment Incentives, page-43

Yes, the FDA are reviewing stem cell guidelines, but that fact does not have the significance with which you have imbued it. Saying the FDA is reviewing its stem cell guidelines is like saying Myers is looking at its supply chain. It's just something that they do, periodically. They're also reviewing biosimilars, the protection of human subjects in clinical trials, cardiac stents, and in all probability, the content of the menu on the FDA canteen.

I didn't say that the FDA wouldn't take note of Japan's moves. I think that's a figment of your imagination.

I haven't said anything about SRX trials - I think you must be confusing me with another of your enthusiastic correspondents. But, as ever, you're getting a bit muddled. SRX has demonstrated the efficacy of their therapy in Phase 3 studies. That the latest trial didn't demonstrate value as a first line therapy, does not diminish it's value as a second line/third line/rescue therapy. The critical issue is that efficacy has been demonstrated, in an appropriate phase 3 study, as a 2nd/3rd line treatment.
Apart from some odd, special access scheme cases, MSB won't be able to sell any products for any indication until it has demonstrated efficacy in a Phase 3 pivotal study - which, to date, it hasn't.
I simply don't understand why raising the efficacy of the Phase 1 and 2 in the context of this discussion is relevant. Leaving aside the issue of whether the efficacy is meaningful - which we will never agree about - you seem to be relating it in some way to SRX, but in typical fashion, you're add 2 plus two and getting a pineapple.

And the bit of my last post you can't be bothered with - would that be the bit where I pointed out that you contradicted yourself in respect the the FDA's attitude to stem cells in the course of a single posting?
Yes, I can see why you might wish to gloss over that.

And these points are not semantics or hair-splitting. You spin up breathlessly positive rhetoric from fragments of misunderstood science, and garbled process, and peddle it as gospel - ostensibly to help those poor mums and dads who don't understand all this complicated stuff!

It's a level of hubris that I've never before encountered.