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11.8% average weight loss as monotherapy in Phase 3 trialsclinically significant and comparable to first-generation GLP-1 medications

Ice crystal formation can damage the peptides structure, and each freeze-thaw cycle may reduce biological activity by 20-50%

Neither BPC-157 or TB-500, the two compounds in REGEN, are approved by Health Canada

Attorneys at Orrick, analyzing the committee's composition, concluded that the most probable outcome is that PCAC will recommend inclusion for some or all of the seven peptides directly against the FDA staff recommendation calling it "a significant departure from prior PCAC precedent." A Gray Market That Will Outlast This Vote For the millions of Americans currently using these compounds, the near-term practical impact of today's outcome is limited in either direction

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The result exceeded that obtained with liraglutide, an approved drug used as a reference comparator in the study