Rivulet Media Inc (fka RIVU)

[ON-Fire]

BMSN-I dont see that they need any approval.They are getting comments on dosing from the FDA to start trials.Check it out.


SAN DIEGO, CA, Mar 18, 2013 (MARKETWIRE via COMTEX) -- Regen BioPharma, Inc., a wholly-owned subsidiary of Bio-Matrix Scientific Group Inc. (pinksheets:BMSN), announced today issuance of IND number 15376 for its proposed Phase I/II clinical trial evaluating use of its stem cell product, HemaXellerate, for treatment of aplastic anemia.

As part of the clinical trial approval process, the FDA will issue comments on the proposed trial which must be addressed to the FDA's satisfaction before patient dosing is initiated. The clinical trial will treat ten patients with aplastic anemia that have not responded to conventional therapy and lack a bone marrow donor.

"We are pleased that the company has been issued an IND number and has taken the first step towards regulatory approval in the USA," said David Koos, Chairman & CEO of Bio-Matrix. "We have compiled an internationally-renowned team, consisting of corporate and academic partners, which cover the manufacturing, regulatory, and medical aspects of the project. Members of the team have previously published with Regen the scientific rational for the trial in a peer-reviewed publication in January of last year which may be found at http://www.translational-medicine.com/content/pdf/1479-5876-10-231.pdf.";