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We further disagree that the proposed requirements are duplicative of the certification requirement at 180.70(a)(2)(iv) as our stated goal for adding the attester name was to provide further reassurance to the public of the accuracy and completeness of the MRF, while the certification requirement is provided directly and only to CMS under the compliance process

In the future, we will conduct clinical trials for examining BPC157 for the treatment of severe trauma and burns

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