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Monday, October 6, 2014

Regen BioPharma Submits Experimental Protocol to FDA for HemaXellerate Aplastic Anemia Trial

The protocol submission was the result of a telephonic meeting with FDA officials, in which the Agency permitted the Company to provide additional input on preclinical safety experiments that need to be conducted before the clinical trial is initiated. "The most important aspect of any novel therapeutic utility in humans is safety of the experimental product.

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