Dallas, Texas 02/11/2014 (FINANCIALSTRENDS) – Chelsea Therapeutics International Ltd.(NASDAQ:CHTP) apparently is in a spot of trouble with its Northera drug. In 2012, the FDA, which is the highest regulatory body in the US refused to accept this drug. However, in the recent months, the drug has been brought back to review. This time the patients under treatment are those who are orthostatic hypotension sufferers. This is the condition where the disease is actually low blood pressure but is of a rare type.
Chelsea Therapeutics International Ltd.(NASDAQ:CHTP) has as per requests placed by the advisory committee, which is the preliminary body to review on behalf of FDA, offered further documents supporting the efficacy of the drug in treating these conditions in the long term. Unfortunately, this has resulted in a sudden fall in the confidence and several investors strode off the radar bring the prices down for this pharma major. There was more news to report for this manufacturer. The advisory committee on the other hand found it a resounding product and backed it by 16 against 1, leading to the approval of the drug.
Chelsea Therapeutics International Ltd.(NASDAQ:CHTP) is thus placed on a rosy peak. Additionally, the panellists have also asked this major to further the trials. This is expected to prove the long term benefits this company will see in the near future.
Chelsea Therapeutics International Ltd.(NASDAQ:CHTP) shareholders however are not sure of the way forward. The advisory committee which is the first-level of investigatory body for the federal government’s tough and stringent review and approval process, only has approved the drug so far. The dilemma for investors in CHTP is, will FDA which is the final authorizing body view the drugs in the same perspective as the advisory committee continues to worry them. The results of final approval or rejection are to be announced by the FDA on Feb 14, 2014.