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
These tests provide information about standard cholesterol, atherogenic particle burden, inherited Lp(a) risk, systemic inflammation, lipoprotein size and number, homocysteine, and omega fatty-acid status
Third-party HPLC-verified to greater than 99% purity, with a batch-specific Certificate of Analysis available on request
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L., Li, Z
The absence of preservatives means sterile water lacks antimicrobial protection once the vial is opened