- Bio-Matrix Scientific Group (BMSN +70.8%) subsidiary Regen BioPharma provides an update on its follow up on the FDA's issues regarding its HemaXellerate IND. On March 6, 2014 the company submitted a protocol modification, additional details on manufacturing, new data on the therapeutic effects of HemaXellerate I in animal models of diseases similar to aplastic anemia in humans and additional safety data to the FDA.
- The agency accepted the clinical protocol and product manufacturing information but requested clarification on the animal safety studies.
- On May 9, the company updated the IND and submitted it to the FDA for review.
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