Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) Hoping for Quick Turnaround


Dallas, Texas 10/08/2013 (Financialstrend) – About a month back on September 5, Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) announced that U.S. Food and Drug Administration (FDA) has in principal agreed to accept its New Drug Application (NDA) for the target drug Northera. The biotech firm hope to hear from FDA about their final decision on the approval in February 2014. The target drug “Northera” is being tested for efficiency in treating symptomatic hypotension in patients suffering from Parkinson’s disease.

Readers should note that In July Chelsea Therapeutics had to resubmit its new drug application for Northera since the original application was appended with electronic data sets which had deficiencies with respect to formatting as also in the language used to explain the method used to arrive at the tables in question.

It was in response to this information from FDA that CHTP had resubmitted its application and received the reported response from FDA on September 5. The drug maker is hoping to get the new application processed in relatively quick time since “Northera” is designated as an orphan drug. FDA has also mandated CHTP to design new tests which will help determine the durability of the target drug over a 60 to 90 day period. This recommendation from FDA comes in the light of Northera being bracketed under FDA “fast track” process for evaluation.

The development stage Bio tech firm has a market cap of $193 million with a net loss of 415.6 million over the past 4 quarters. It has a total of $67 million outstanding shars of which 36% is owned by institutions.      As of close of business on October 7, the stock is trading 3.6% down from its previous week valuations. It was trading at $2.88 per share which translates to a 12% dip from its 52 week high valuation. It has a total of 18 full time employees.