Might better change your handle from gain cube to lose cube. Sounds like you like to play pin the tail on the donkey with your money. Hope it turns out in a good way for you. You can pick some more shares for around a dollar in a few weeks.
yo gain u r an f=n idiot...all in with pension yet you are asking for others info on yahoo mb-seriously??...do your own f=n DD dumazzz. un-f=n-believeable-ROFLMAO. go to vegas put your pension on red and as the marble being spun on wheel then ask guy next to you what game is this??????? moron.
Monday, July 29, 2013
Venaxis: Well-Funded Ahead Of Multiple Catalysts Expected Through Year-End
In mid-July, APPY successfully completed the first of two planned interim futility analyses on 579 of 2,000 subjects in ongoing pivotal US (FDA) clinical trial (ClinicalTrials.gov ID NCT01652170) with a second futility analysis (1,200 subjects) expected around the end of Q3 2013 and top-line results expected around year-end 2013 to support a planned FDA 510(k) de novo medical device filing during Q1 2014.
APPY conducted a Q2 2013 update conference call (click here for Seeking Alpha transcript) after the first futility analysis was announced, which included updates on the clinical trial progress and outlook in addition to an update on the financials and upcoming European commercialization milestones that are reflected in this article.
In January, APPY received the CE Mark (Europe) as a blood-based diagnostic test focused on children and adolescents suspected of having appendicitis to help identify low-risk subjects and avoid unnecessary testing (i.e. unnecessary radiation exposure from CT scans) to support a full European product launch next year with expected European market development agreements and completion of the first outcomes study by the end of Q3 2013 with initial data to follow during Q4 2013.
APPY1 is a 20-minute test that is based on three parameters, including two measures of inflammation (MRP-8/14 and C-reactive protein) and the white blood cell count. The individual parameters are entered into an algorithm, which calculates the AppyScore that is displayed on the reader display unit with the goal of identifying patients at low risk of appendicitis to avoid the unnecessary costs and radiation exposure that is associated with CT scans.
In March 2012, APPY reported the results of a 500-patient pilot study, which indicated a high sensitivity of 96% and negative predictive value of 97% in subjects age 2-20 with symptoms suggestive of acute appendicitis presenting to the emergency department. While the specificity from this study of 43% is low; the high negative predictive value of the test from the study is more important, since these patients would not receive more extensive follow-up testing and therefore, undergo more conservative management for what could be a serious, life-threatening condition if the appendix bursts to cause massive internal bleeding.
In the Company's June presentation, APPY has outlined market / revenue potential for the APPY1 test that is summarized in the slide below and includes a low amount in 2014 followed by more meaningful sales potential starting in 2015 that will quickly flow to the bottom line due to a lean business / capital structure for APPY that will not require blockbuster sales to reach sustained profitability. APPY has provided preliminary guidance for pricing the APPY1 test in the $75-80 range with European pricing expected to be in the $40-50 range due to the involvement of distributors in that region which will buy the product at a discount from APPY for resale.
Sentiment: Strong Buy
Somebody might know something here. APPY has the best looking chart and indicators for now. I don't believe it is a bull trap. You own me a big apology if APPY flies to moon tomorrow.
Sentiment: Strong Buy