Chelsea Therapeutics (CHTP) Slammed on Northera Delay
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Chelsea Therapeutics (Nasdaq: CHTP) is getting slammed early following delay to its Northera approval. Shares are down 50 percent in early trading.
According to the release: "In its response, FDA advised Chelsea that, based on the theoretical potential for certain patients from Study 306B to have been unblinded in conjunction with the reporting of 306A data, the FDA cannot be confident that this information did not influence an amendment of the statistical analytic plan, and therefore believes, as presently planned, Study 306B is unlikely to provide sufficient confirmatory evidence to support a Northera™ (droxidopa) Capsules New Drug Application (NDA)."
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According to the release: "In its response, FDA advised Chelsea that, based on the theoretical potential for certain patients from Study 306B to have been unblinded in conjunction with the reporting of 306A data, the FDA cannot be confident that this information did not influence an amendment of the statistical analytic plan, and therefore believes, as presently planned, Study 306B is unlikely to provide sufficient confirmatory evidence to support a Northera™ (droxidopa) Capsules New Drug Application (NDA)."
For more, click here.
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