FDA places clinical hold on vTv's cadisegliatin clinical program

seekingalpha07-27

VTv Therapeutics (NASDAQ:VTVT) said the FDA has placed a clinical hold on its cadisegliatin clinical program, which includes the CATT1 Phase 3 study of the product for the treatment of type 1 diabetes...

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The biotech company said the hold was placed “based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion study of cadisegliatin that could not be resolved by standard mass spectroscopy.”  VTv  added that the FDA is requiring a single in vitro study be conducted to characterize the signal before the program can resume, according to a statement. 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The biotech company said the hold was placed “based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion study of cadisegliatin that could not be resolved by standard mass spectroscopy.”  VTv (VTVT) added that the FDA is requiring a single in vitro study be conducted to characterize the signal before the program can resume, according to a statement. 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