Chelsea Therapeutics (CHTP) Slammed on FDA Complete Response for Northera Caps
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Shares of Chelsea Therapeutics (Nasdaq: CHTP) shares are getting slammed Thursday morning, following an update to its Northera (droxidopa) Capsules NDA submission to the FDA.
According to the release: "The complete response letter includes the request by the FDA that Chelsea submit data from an additional positive study to support efficacy demonstrated in Study 301 along with the recommendation that such a study be designed to demonstrate durability of effect over a 2- to 3-month period...In addition to the clinical requests, the FDA indicated that additional bioequivalence work would be needed to support the approval of a 300mg capsule that Chelsea was considering making commercially available to complement availability of the 100mg and 200mg capsules utilized in Chelsea's clinical program, but would not required this for approval of the NDA."
Shares are over 20 percent lower ahead of the bell.
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According to the release: "The complete response letter includes the request by the FDA that Chelsea submit data from an additional positive study to support efficacy demonstrated in Study 301 along with the recommendation that such a study be designed to demonstrate durability of effect over a 2- to 3-month period...In addition to the clinical requests, the FDA indicated that additional bioequivalence work would be needed to support the approval of a 300mg capsule that Chelsea was considering making commercially available to complement availability of the 100mg and 200mg capsules utilized in Chelsea's clinical program, but would not required this for approval of the NDA."
Shares are over 20 percent lower ahead of the bell.
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