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Carnosine dipeptidase II (CNDP2) protects cells under cysteine insufficiency by hydrolyzing glutathione-related peptides
The FDA noted that the firms post-inspection response described new smoke studies and corrective actions but failed to include the actual protocols or completed studies as supporting documentation
Known risk factors include, among others: the expected benefits and opportunities related to the collaboration and the companion diagnostics may not be realized or may take longer to realize than expected due to challenges and uncertainties inherent in product research and development
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