Yesterday afternoon I talked to Steve Schultz at Acusphere for over 30 minutes. This is a summary of our conversation and the list of questions I asked him. His answers are not direct quotes but I did take notes and tried hard to represent him as accurately as possible. I didn't really find out anything new or earth shattering but I will share this with you anyway. Steve was very open and conversational and let me know I could call back anytime with questions.Q. Now that some time has gone by since the release of Ramp 2 results, what has the feedback been like so far from the medical community?A. We surveyed about 50 doctors after the Ramp 2 results and the response was incredibly enthusiastic. About 70 or 77 percent said they would use Imagify in their practice. Imagify was very well received at the ASEC in Seattle this year.Q. What about from the FDA, what has their feedback been so far since Ramp 2?A. They have not responded to the data yet but they are not expected to. We have been in pre-NDA meetings with the FDA.Q. What has the negative or doubtful feedback been; what makes people hesitate?A. The unknown regulatory process is what makes people hesitate.Q. What do people in the medical community and in the FDA say about the “2 out of 3 endpoints met” trial results?A. The medical community understands this completely, the tradeoff between specificity and sensitivity; they manage this balance every day. We feel that accuracy is most important. The sensitivity/specificity could possibly influence the breadth of label. ***During our conversation Steve mentioned the real world scenario where patient data is available and how this influences reading the images. I asked if the FDA considers this real world scenario or if they just look at the trial data. Steve said the NDA package is over a thousand pages long and the company submits an argument to support their claim.Q. Ramp 1 emphasizes specificity, Ramp 2 emphasizes sensitivity. Can I read this design somewhere?A. No, but when we went to the FDA to design the tests we said we wanted to go after nuclear stress tests. The Ramp 1 and Ramp 2 design was to test a wide patient population in order to compete with nuclear.Q. How long to NDA approval or rejection?A. 60 days for the review/acceptance process then 10 months of review. One year. I asked about fast track just for fun and he said no.Q. What about the NDA in Europe? Will it be filed at the same time as the U.S. NDA and how long until the decision?A. We will be working with Nycomed and the NDA will be filed shortly after the US NDA.Q. Will the NDA be filed early in Q4?A. We have not released a more specific time yet.CONTRAST ECHO FOR PERFUSION: CONVINCE US! MGH/HarvardPrinciples of myocardial contrast echocardiography – Paul A. Grayburn, MDCASE STUDIES: Perfusion imaging with echo contrast- Ready for Prime-Time – Michael H. Picard, MDPaul A. Grayburn, MDMarielle Scherrer-Crosbie, MDQ. Do you know all of these doctors and do you know what their opinion of Imagify is?A. Picard was the medical monitor and he is very bullish, as he has said on the cc. I do not know the views of the other two doctors.UNMC researchers find breakthrough microbubble technology more effective, less invasive, less costly in detecting heart disease . University of Nebraska Medical Center researchers have discovered a new way to detect heart disease that traditional tests would have missed in patients with diabetes without symptoms. Q. Will this test be included in the NDA?A. No, this is a separate test.Q. Is stress echo with Imagify better than stress echo as it is currently performed?A. The answer is yes in certain applications. Current tests use wall motion. Perfusion is more sensitive. If a patient has advanced heart disease where the patient has an irregular heart beat, the current tests will detect it. If there is blockage but disease is not as advanced, the perfusion info will allow detection of disease that would be missed using wall motion alone. Nuclear uses perfusion and that's why ¾ of tests are done using nuclear.Q. Is there something I am missing? Why the low stock price? Imagify seems like a gold mine?A. We believe we have positive phase 3 data and we should have a strong NDA. This is a multi billion dollar opportunity. The story is misunderstood by investors because of the missed endpoints. The trial was not a therapeutic trial where there is generally one endpoint. The complicated trial design confused investors who were looking for a home run. It is difficult to remove the confusion but we are making ourselves available to investors and are working on getting the word out.Q. What is the new development opportunity you will be announcing? Is the HDDS technology?A. It's a reformulation but it's not AI-850.-Marc
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