Deutsche Bank Reiterates a 'Hold' on Chelsea Therapeutics (CHTP); Saga With FDA Takes New Turn

July 3, 2012 10:55 AM EDT
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Deutsche Bank reiterates a 'Hold' on Chelsea Therapeutics (NASDAQ: CHTP).

Deutsche analyst said, "FDA is concerned that the suggested trial amendments to Study 306B, which is evaluating Northera vs. placebo in NOH patients, were based on Chelsea having unblinded the trial. In speaking with Chelsea, this is not the case and the trial remains blinded. The FDA is taking a theoretical approach that Chelsea may have received hints of data from its CRO that would allow it to design the trial to work. The FDA has stated that Chelsea's 306b would not be adequate for approval due to this theoretical risk."

Overall, the Deutsche analyst would feel more comfortable if a trial on the higher-end or longer than 3 months was implemented

For an analyst ratings summary and ratings history on Chelsea Therapeutics click here. For more ratings news on Chelsea Therapeutics click here.

Shares of Chelsea Therapeutics closed at $1.46 yesterday.


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