Show us some examples where the FDA has given approval for...

Show us some examples where the FDA has given approval for commercialisation after a Phase 2 trial?

Off the top of my head I know of no examples but that is surprising to me as that is not how I work. I work on underlying principles - trying to get those right. Science and FDA procedure.

Scultor in Australia went straight to phase 3 because it was robust enough in design. It was not designed by Cynata.

Nothing in the many FDA documents I read explicitly prohibits a single large multisite trial being sufficient -- provided it is an adequate and well controlled trial - and (I'm recalling not reading - there are additional sources of evidence outside the trial itelf.

The FDA usually wants two trials. The requirement to do good science will usually require two trials because usually things will be discovered in the phase two that need further clarity to be teased out in phase three.

But the actually difference between MSCs from iPSCs and MSCs per se as MSB and others have done them are likely no great - I think the long history of safety in MSCs will carry over to CYP iPSC derived MSCs - provided some safetly specific matters are addressed peculiar to iPSCs - and for the most part they have been already - the cells don't implant, they are transitory.