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Cadence Pharmaceuticals Inc. Q2 2010 Earnings Call Transcript

Ted Schroeder

Good afternoon everyone and thank you for joining us today. I will start by providing a brief summary of the second quarter events and provide an update on our efforts to obtain regulatory approval for OFIRMEV, our intravenous acetaminophen investigational product candidate. Bill then provide an overview of the second quarter and year-to-date financial results. After the financial results, we will open the call for your questions.

First, I would like to provide a brief update on our NDA for OFIRMEV. As we have discussed previously in February of this year, we received a complete response letter from the FDA, which stated that our NDA could not be approved due to deficiencies with respect to good manufacturing practices observed during the agency's inspection of the facilities of our third-party manufacture.

Following a meeting with FDA to discuss the observations, we resubmitted our NDA for OFIRMEV in May, and we are subsequently notified that the FDA had classified our resubmission as a complete class to response to the February letter. We have received a new PDUFA action date of November 4, 2010 and our third-party manufacturer has responded to the deficiencies noted during the inspection of the manufacturing facility. We have not been notified by FDA, as to whether or not the agency will re-inspect the manufacturing facility prior to completing its review of our NDA.

In the mean time, we are working with our third-party manufacturer to ensure that they are ready to supply commercial product as soon as the NDA is approved. We are finalizing our commercial readiness activities in order to be well position for a strong launch of OFIRMEV as soon as possible of following approval by the FDA.

We also announced the very exciting opportunity for our company in the second quarter. In June we signed an agreement to secure an option to acquire Incline Therapeutics, a newly formed privately-held specialty pharmaceutical company.

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