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A Notice of Proposed Rulemaking, issued in November 2014, addressed the issue of whether results from unapproved, unlicensed, or uncleared products should be reported

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To translate BPC157 into the clinic, we previously conducted preclinical safety studies and found that BPC157 was well tolerated and did not demonstrate serious toxicity ( We studied the pharmacokinetics of BPC157 after its IV and IM administration in rats and beagle dogs

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