Molecular Insight Pharmaceuticals F2Q07 (Qtr End 9/30/07) Earnings Call Transcript

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2007-11-12 14:12:39.0

Tags: Molecular Insight Pharmaceuticals Inc.

Question-and-Answer Session

Operator

(Operator Instructions) Your first question comes from the line of Adam Walsh, with Jefferies & Company. Please proceed.

Adam Walsh - Jefferies & Company

Good morning, guys. Thanks for taking my questions.

David Barlow

Hello Adam.

Adam Walsh - Jefferies & Company

My first here is for John. John I get this question a lot from investors and I wondered if maybe you can clarified here on the conference call today. When the first Zemiva pivotal trial data comes what should we be looking for in terms of sensitivity, specificity and positive and negative predictive value? Thanks.

John Babich

Thank you, Adam. As you are aware of the, show me the data from the Asthmatic presentation, which reviewed our Phase IIb data, we had strong sensitivity data in terms of supporting sensitivity and negative predictive value. And we believe in regards to what the FDA is looking for and also what our clinicians are looking for are really key, those are the key findings.

Sensitivity, particularly in patients with Troponin positive biomarkers was one of the things that was particularly important in terms of the Phase IIb trials and as you recall, a 100% of the patients with positive Troponin biomarkers were positive for Zemiva scans as well.

We are looking at 80, around 80, in the 80s for sensitivity for the ultimate trial. We are looking at a higher negative predictive value in the 90s and we expect those to be the levels on which the FDA is going to be holding us to.

Adam Walsh - Jefferies & Company

John, can you just quickly touch on positive predictive value and specificity.

John Babich

In regards to what's in the market today, if we go back to the current drugs that are approved for the detection of cardiac ischemia and CAD. Those drugs were approved with sensitivities in the 60s, mid 60s and specificities around 50% little higher than that.

What we are looking at in terms of our own specificity in the Phase IIb that was presented at Asthmatic is around 60%. And this is probably driven in some degree by finding disease and patients that are suffering from chronic CAD and not necessarily by Coronary Syndrome, and so well we do have some false positives under the technical term of ACS.

We believe we are finding disease and its an important finding that we're not, we actually have some positive scans that are finding disease, underlying disease in patience that maybe driven by hypertension or chronic CAD.

 

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