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Post# of 251748
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Alias Born 05/05/2006

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Saturday, 09/29/2012 8:48:44 PM

Saturday, September 29, 2012 8:48:44 PM

Post# of 251748
APPY 7 MM float + 30% to $2.75, could go to $10 IMO

APPY could be next RPRX or ROSG
- 7 MM float
-Proven appendicitis test with $1 BIllion potential market
-Will market in Europe later this year, US approval likely in 2013

Over 9 million patients present annually to ERs in the US with abdominal pain. This is the single largest reason for ER visits. We believe that approximately 6 million of these patients would be candidates for our blood test. We have not finalized pricing for the test but we believe pricing will be in the $100 range. When we take into account the international opportunity, we believe the global market size to be in the $1 billion range. QUESTION- What is the status of the product? Answer- In 2011 we completed a 503 patient study across 11 hospitals in the United States. The performance was excellent; the test performed at a negative predictive value (NPV) of 97%. Clinicians have indicated that they would be highly motivated to order a test that performs at this level. Our next step in the US is to complete an FDA pivotal trial which is scheduled to start in Q3 of 2012 and finish in Q1 of 2013. The FDA trial will be very similar in design to the study we completed in 2011. We plan to launch in Europe in Q4 of 2012; there is no requirement for an FDA pivotal trial for European launch

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