Rick will provide a little more color on this shortly. We’ve begun the recruiting process for our key management positions and are engaging with a contract commercial organization to build on our field personnel. Our initial focus is to place medical science liaisons and market access specialists in the field to cultivate the market for our formal launch early next year. In July, we received a letter from Germany’s Federal Joint Committee indicating that the automatic obligation to submit a dossier on ILUVIEN per the AMNOG Law would not be necessary, and that a benefit assessment would not be required.
This is due to the fact that fluocinolone acetonide, the active ingredient in ILUVIEN, was available on the German market prior to January 2011. This allows us to launch ILUVIEN without price restriction in Q1 of 2013. Following Germany, we expect to launch in the United Kingdom and France later in 2013.
Regarding the UK, there has been misleading and incomplete information recently around the issuance of the Appraisal Consultation Document or ACD (ph) that we received from the National Institute for Health and Clinical Excellence or NICE. NICE publishes ACD as part of the Single Technology Appraisal process. Following the first appraisal committee meeting, the committee acknowledged that ILUVIEN showed greater efficacy than a sham injection in people with chronic diabetic macular edema. However, their preliminary recommendation is that ILUVIEN is not recommended for the treatment of chronic diabetic macular edema given the current cost of ₤5,500 and other variables included in our submission.
As some of you may or may not know, the process with NICE requires the submission of a cost affecting this model. As you can imagine, this model is extremely complex with multiple variables, only one of which is obviously price. We have reached agreement on the majority of the variables in the model. However, there do remain some assumptions that are still open for discussion. This document is not NICE’s final guidance on the technology and the recommendation may change after consultation. We, along with NICE’s consultant and the public, have the opportunity to provide further comments by the end of August in preparation for the second appraisal meeting in September. This interim guidance provides us additional information on key issues and important variable in NICE’s evaluation of the cost effectiveness of ILUVIEN.Read the rest of this transcript for free on seekingalpha.com
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