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The FDA issued guidance in 2023 stating BPC-157 cannot be compounded by 503A or 503B pharmacies in the United States because it is not on the approved bulk substances list
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Proposed Mechanism of Action In theory, the vaccine works by: Delivering mRNA instructions encoding tumour-related antigens Presenting these antigens to immune cells Activating cytotoxic T-cells Directing immune attack toward cancer cells Despite these theoretical mechanisms, several key questions remain unanswered: Which tumour antigens are targeted Which cancer types are included Whether immune activation leads to real tumour shrinkage How long the immune response lasts What side effects may occur
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