In addition to developing the European market, Venaxis is actively focused on training hospital sites for its pivotal clinical study of APPY1 in the United States. Most sites are prepared to begin enrolling patients into the study, with training either completed or scheduled for near-term completion with laboratory personnel at the participating sites. Ultimately, the study is expected to enroll a total of approximately 2,000 net evaluable patients at approximately 28 hospital emergency departments across the United States. In parallel, the FDA recently offered Venaxis the option to conduct a follow-up call to discuss the protocol enhancements made by the Company following its September pre-IDE meeting. Venaxis will take advantage of this opportunity, and accordingly, the follow-up call has been scheduled for early January. Venaxis plans to commence patient enrollment after the follow-up call with the FDA is completed and continues to anticipate that all hospital sites will be on-line and enrolling patients in early 2013.Steve Lundy, President and CEO of Venaxis, stated, "We are currently prepared to begin enrolling patients into the pivotal study; however, we believe it is in Venaxis' best interest, and the best interest of our shareholders, to leverage every available opportunity to interact with the FDA. Therefore, we welcome further discussion of the APPY1 U.S. regulatory process, in an effort to maximize our potential for successful clearance of our test. As we move forward with our commercial plans in Europe, we are encouraged by the FDA's ongoing dialogue with us regarding our pivotal U.S. study. As we continue our clinical development, we look forward to completing the pivotal trial, sharing the outcome and data with you when it is available, and submitting it to the FDA for such clearance."
Venaxis Files For CE Mark And Prepares For European Commercialization
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