$BMSN -- Filed IND application w/ FDA!
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On February 5th, 2013 Regen filed an Investigational New Drug (IND) application with the FDA to initiate clinical trials using HemaXellerate for treatment of patients with aplastic anemia that are resistant to current therapies. The FDA issued IND # 15376 to Regen in response to the Company's IND application. The Company has been in communication with the FDA, which informed us that, as per FDA procedure, a letter outlining items which must be addressed prior to initiating clinical trials will be sent to us shortly. Regen is confident the Company will be able to address these items to the FDA's satisfaction. It is the goal of the Company to initiate clinical trials by Q4 of 2013. Additionally, aplastic anemia is considered an Orphan Disease and we plan to apply for Orphan Drug Status during clinical development.
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