Chief Executive Officer of the Company reminded that the Issuer received clinical trial registration approval from the FDA just over a month ago, so the Board of Directors of the Issuer is pleased with the rate of enrollment in this relatively short time. The Company plans to enroll up to 400 patients in the trial at four separate sites in the U.S. Upon achieving full enrollment, the Company expects the clinical trial and accompanying statistical analysis to be completed in the third quarter of 2015, at which time the Issuer will return to the FDA for final market clearance.
Legal basis: Section 3.1 of the Exhibit 3 to the Alternative Trading System Rules “Current and Periodical Information in the Alternative Trading System on the NewConnect Market
Źródło:Komunikaty spółek (EBI)
