Boston, MA – (NYSEPOST) – 02/10/2014 – Last month, Northera, Chelsea Therapeutics International Ltd (NASDAQ:CHTP)’s lead drug-candidate received very strong support from a United States Food and Drug Administration’s advisory-panel. This raised the prospects of Northera receiving he nod from the regulators. In March 2012, the food and Drug Administration had rejected the blood pressure drug and Chelsea Therapeutics International Ltd (NASDAQ:CHTP) had been asked to provide some more efficacy data on its drug. The regulator then accepted the application that the company resubmitted in September, post a year-long delay in commercializing the drug.
This resubmission by Chelsea Therapeutics International Ltd (NASDAQ:CHTP) included some additional information that would resolve some technical deficiencies that the regulator had identified. Most of these deficiencies were connected to formatting of some electronic data-sets that had been submitted by the company as well as certain statistical programs. In a research note, Wedbush analysts said that the vote that was given by the advisory panel’s, of 16 to 1 was given inspite of the negative tone from the Food Drug Administration in the briefing documents. Chelsea Therapeutics International Ltd (NASDAQ:CHTP) said that they felt that the panel had appreciated the vagaries that exited in the clinical-trial in the treatment of neurological disorders.
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This was especially true in orphan diseases such as symptomatic neurogenic orthostatic hypotension and the fact that there were very few good alternative treatments available. It must be noted that the FDA is not required to follow the recommendations that are put forth by the panel. But the fact also remains that the response from the panel has been an overwhelmingly positive one and that might pressurize the regulator to give its approval for Northera. Even way back in 2012 February, the panel had recommended that the drug be approved, but at that point of time the vote had a much smaller margin.