A mí también me entró bajonazo framus, no contaba con lo de la UE... Bufff, potencial tiene, pero esperaba que fuese de aquí a final de año. Dejo el extracto dónde lo dice:
"Beyond our activities in the United States, we're proceeding with our marketing applications in the European Union and Switzerland. Our centralized submission in the EU was accepted for review in March. The EMA process is a little bit different from that of the FDA. In the first half of the process, the EMA's Committee for Medicinal Products for Human Use or CHMP, completes the review of the MAA and provides their feedback in the form of a 120-day assessment report and list of questions. The questions will need to be addressed before Lorcaserin can be recommended for approval. We have now received this report and are in the process of preparing our response. The report provides CHMP's quality, clinical and nonclinical questions and comments, which include a similar range of issues previously raised by the FDA. Three were identified as major observations: The tumor findings in rats; the drop out rate in clinical studies and how this affects the analysis of efficacy; and the incidence of valvulopathy. We plan to respond to the CHMP next quarter and based on this timeline, we expect a decision on our EU application at some point in the first half of next year.
We've also submitted an MAA in Switzerland on July 11, our third application for regulatory approval. This submission was accepted for review by Swissmedic at the end of July. In addition, we've completed our transfer of the U.S. new drug application to Eisai. The NDA transfer establishes Eisai as the Marketing Authorization Holder responsible for marketing efforts and for regulatory compliance in the United States. We will continue with our manufacturing responsibilities, as well as to lead the global development of BELVIQ.
Eisai also plans to use our Lorcaserin dossier and our product expertise as the basis for its marketing applications in the additional territories in which it holds commercial rights, focusing first on Canada, Mexico and Brazil."
Fuente: http://seekingalpha.com/article/798541-arena-pharmaceuticals-management-discusses-q2-2012-results-earnings-call-transcript?page=3