Replies to post #118484 on Rivulet Media Inc (fka RIVU)

[Canadian Trader]

I think it is something they are expecting to occur for HemaXellerate I. I'm not familiar with the process, but it may officially come about once the clinical trials are underway.

From the 12/11/13 PR:

"...the Company believes it is well positioned to develop the product as the first regenerative medicine solution for drug resistant aplastic anemia, an indication which qualifies for Orphan Drug Status."

[Angry Goat]

Incorrect.

The paperwork for FDA IND approval to start clinical trials has been submitted. This was submitted ~ 1 year ago. The company is hoping to get Orphan status to expedite its testing and get it to market faster than the normal route assuming the procedure works in humans (it has never been tested in humans, only rats.)

The FDA alerted the company ~ 6 months ago it needed further tests before approving. The company has performed those test but it is not clear if the data has been submitted to the FDA for re-inspection.

So, we wait to see if the FDA actually approves HemaXellerate 1 for IND/Orphan status. That is what will either make or break this company.