Looks mighty promising to me for the near future trade. And in comparison to ACTC it is clear NVIV is going after the high hanging fruit and does not have the same market potential like ACTC but IF they can pick that fruit, the market potential in other indications. will be more than massive.
It's great to read that the FDA wrote new guidance-it explains so much everywhere. But suppose NVIV had to revise their paperwork to meet the new guidance, which also means a pre-app discussion again-author's 45-days???-unless the original app was good "as is".