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As the only deficiencies relate to the FDAs inspection of our third-party contract manufacturing organization, we believe we can address the feedback in a resubmission to enable marketing approval in 2024, James Oliviero, the companys president and CEO, said in a statement

This 16 amino acid peptide originates from an open reading frame within the 12S rRNA gene, making it a product of mitochondrial rather than cytoplasmic translation

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