Rivulet Media Inc (fka RIVU)

[cvinvestor]

GM,
PR only says a modified IND per FDA requests was submitted on May 9th. The good news is that Regen and FDA are working and going forward to this point which gives us hope for final approval, but PR does not, for reasons only they know, give us clarity as to what the nature of the modifications are to the IND. Does not say that they submitted responses or further data, only that a modified IND was submitted which I found curious. And the fact that Ichim's quote refers to general sense of medical community seeing promise and wanting these types of treatment to go forward rather than specifying what the issue was about the safety and how they were to address it.

You are right, we are back in a 30 day window it seems for FDA to respond to modified IND it seems, but my gut says that the IND is much narrower and the safety issue for broad Hemaxellerate usage may take more time.

I'm going to say no more studies as the new information has already been submitted on May 9th.