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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

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Every batch of Koi BPC-157 is synthesized and lyophilized in the United States, then released against independent third-party laboratory (Freedom Diagnostics Testing) testing