The EMEA also bolstered Encysive, sending its stock up 44 percent, with a recommendation in favor of the high blood pressure medicine Thelin. Thelin is Encysive's lead drug candidate. Just days ago, Encysive responded to the FDA's appovable letter from earlier this year, which had sent shudders through the ranks of analysts worried the agency might demand another trial of Thelin.
"The CHMP's positive opinion will now be considered by the European Commission, which is expected to issue a final decision regarding marketing approval for Thelin within approximately 90 days," Encysive noted. "Under the EMEA's centralized licensing procedure, if approved, Encysive would be granted marketing authorization for Thelin in all 25 member states of the European Union."
- read the article from TheStreet.com
- and here's more on the analysts and the FDA