Everyone remember that the regulations governing stem cell treatments and CT's are still evolving. And remember, too, only a handful of companies, with mega experience, submit an IND and experience no Q&A with the FDA thereby allowing them to go by the "no news is good news" approach.
The HemaXellerate application was the first for BMSN. It was the first submitted with a request to conduct trials in a very new market. Q&A is GREAT. It means the FDA didn't look at it and say "get the you-know-what out of here".
The efficacy data was generated and submitted sometime before 17 July. For all intents & purposes, they could find out anytime. And as I have stated, more than likely sooner than later.
GO BMSN!