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A Phase 2 trial (NCT01311518) was designed to test RGN-352 in ~75 heart attack patients, but was placed on FDA clinical hold in 2011 due to manufacturing (GMP) compliance issues at the contract site — not safety concerns with the drug itself

Tissue Repair Supplement

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A 30 mg vial reconstituted with bacteriostatic water yields about 10.0 mg/mL

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