Dallas, Texas 08/12/2014 (FINANCIALSTRENDS) – Amarin Corporation plc (ADR)(NASDAQ:AMRN) is moving rapidly up on stock markets as of Monday, given the current processes that FDA is currently engaged in, with respect to its flagship product , VASCEPA.
FDA Plays For Time
As some insiders speculate, FDA is currently reviewing Vascepa, in terms of the legal implications of its approval over its scientific technicalities. The ‘review process’ will allow FDA to gain leverage on the time factor as it mulls over the effects of the commercial use of the drug.
Amarin Corporation plc (ADR)(NASDAQ:AMRN) had on Sunday announced its earnings results. As part of the earnings call, the management noted that there were several areas in which the company noted changes. The highlight of the quarter’s performance is the sales as well as the prescriptions for Vascepa.
Based on these reports analysts believe this stock is attractive positioned for investing.
John Thero Appeals Do Not Move FDA
Amarin Corporation plc (ADR) (NASDAQ:AMRN) President John Thero appeal on FDAs move to introduce off-label for Vascepa. However, apart from wiggling for time factor so as to take care of the legal implications there do not appear to make any impact on the regulatory bodies stance with respect to the drug.
In the second quarter, there was increase in the patient enrolment as well, for the REDUCE-IT study. The number of volunteers for this stage of testing for Vascepa now has 7,000 patients from the pool of 8 000 patients for cardiovascular outcome trail set. The quarter also saw the collaborative research projects on Vascepa, with the publication of ‘retrospective analyses of over 14 patient cases located in Western New York. The examination includes the effect of lipid parameters during the hyperlipidemic patients. It was noted that, Omega-3 switched patients showed improvements in the constitution of triglyceride as well as the low-density lipoprotein cholesterol standards.