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News Breaks
November 13, 2012
16:22 EDTAPPYAspenBio Pharma expects CE Mark for diagnostic test before year's end
AspenBio Pharma provided a clinical and business update for Q3. The company reported it has started the hospital training phase of its pivotal U.S. clinical study and remains on track to initiate patient enrollment before the end of the year. AspenBio also reiterated its anticipated timeline for obtaining CE Mark for its lead blood-based diagnostic test by year end, and provided an update on market development activities in Europe, including its discussions with potential commercial distributors. AspenBio expects to continue training the remaining hospital sites on the trial protocol over the coming weeks in order to advance to patient enrollment before the end of the year. Once enrollment commences, the study is expected to enroll a total of ~2,000 net evaluable patients at approximately 25 hospital emergency departments across the United States. AspenBio plans to complete this study, file for marketing clearance, and upon receipt of such clearance from the FDA, launch the product in the U.S. in late 2013. In Europe, the Company is currently pursuing agreements with top distributors in what AspenBio believes will be major sales territories, including Germany, UK, France, Italy and Benelux. The company expects to file for and obtain CE Mark for its diagnostic test before the end of the year and hopes to be positioned to commence sales and distribution efforts as soon as possible thereafter. At September 30 the company had $10.2M in cash, cash equivalents and short-term investments. AspenBio believes it has sufficient cash to complete the planned pivotal trial, as well as launch the product in
News For APPY From The Last 14 Days
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January 30, 2015
10:00 EDTAPPYOn The Fly: Analyst Downgrade Summary
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08:39 EDTAPPYVenaxis downgraded to Hold from Buy at Canaccord
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January 29, 2015
14:43 EDTAPPYVenaxis downgraded to Hold from Buy at Craig-Hallum
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09:06 EDTAPPYOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Flextronics (FLEX), up 6%... Coach (COH), up 6.3%... Autoliv (ALV), up 4.3%... Dow Chemical (DOW), up 3.5%... Ford (F), up 0.8%. ALSO HIGHER: McDonald's (MCD), up 3% after announcing CEO change...Xencor (XNCR), up 19% after reporting results from two trials... Pluristem Therapeutics (PSTI), up 8% after providing update and outlook on trials and pipeline... Avon Products (AVP), up 2.3% after naming James Scully as CFO... Omeros (OMER), up 6% after 2.996M share spot secondary priced at $20.03. DOWN AFTER EARNINGS: Alibaba (BABA), down 8%... Qualcomm (QCOM), down 6.8%... Alexion (ALXN), down 1.1% after reporting fourth quarter results, fiscal 2015 guidance, and CEO appointment. ALSO LOWER: Yahoo (YHOO), down 7% following Alibaba earnings report... Venaxis (APPY), down 72% after its APPY1 Test was determined by the FDA to not meet the criteria for substantial equivalence.
06:46 EDTAPPYVenaxis' APPY1 Test 510(k) submission turned down by FDA
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