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Thursday, May 18, 2006 11:24:26 AM
Philip Young - Insmed Incorporated - Chief Business Officer
Okay, thank you, Matt. Thanks for calling and thanks for your questions. First off, yes, you are correct. We do plan to launch and fill our first prescriptions for IPLEX over the next several weeks,and we are on track for doing that. The EU strategy is pretty straight forward. Once we received FDA approval and were able to focus on the European market, we decided that filing in the EU would give us more leverage and a better bargaining chip with potential partners in the European sector. So our goal now is to file the application in the third quarter and then focus on whether we partner or do it ourselves. We'll be taking those discussions and those decisions over the second half of this year and then moving forward with that. As we've said in the past, we have had discussions with several potential partners over there, but we've decided not to pull the trigger on any activity now, until we get the file completed and accepted for review by the EMEA authorities.
According to Phil, they have not filed yet, so how can the EMEA be reviewing their application? My guess is that this is not about the application but something else. As you stated the drug was given orphan designation (which is not the same as orphan marketing) back in 2004.
I'm confused.
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