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The agency says it has only limited safety information for the proposed methods of administration and cannot determine whether the compound would harm humans

The actual statement supported by the data is: BPC-157 accelerates Achilles tendon healing in rats in a specific experimental injury model. These are not equivalent claims

By resisting immediate degradation, the sustained-release formula allows the intact tripeptide to gradually enter the intestinal tract, where it is slowly absorbed over an extended period

More specifically, the agency recommended that the consultant conduct a six-system audit of its operations to assess CGMP compliance and evaluate its CAPA processes