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Safety Concerns: Without comprehensive human trials, the FDA cannot assure the safety of BPC-157, including potential side effects, long-term impacts, and appropriate dosages

82 ShibataT.KokubuA.SaitoS.Narisawa-SaitoM.SasakiH.AoyagiK.et al (2011)

TB-500 supports tissue repair by promoting cell movement, reducing inflammation, and improving blood vessel formation within damaged tissue

The results of the study indicated a significant decrease in the attack frequency, number of headache days, and headache severity in the group treated with the supplement (600 mg for 3 months) (150)

If the agency ultimately issues a final determination against listing, compounders would lose any viable legal pathway though substances can be re-nominated in future PCAC cycles or challenged in federal court