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Biotech / Medical : PSDV - pSivida Limited

PSDV 1.220

+14.0%

Mar 29 4:00 PM EDT

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From: John McCarthy	8/17/2012 2:12:40 AM
	of 421

This is WEIRD. On the CC - ALIM expects the UK to approve Iluvien The pissing contest is simply about $$$$. ALIM went in with a cost of 5,500 pounds per shot. And NICE is looking for something lower. Here is the CC: 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 submissio 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. The final appraisal determination or FAD is not scheduled until November. We look forward to responding to the committee and working toward a positive recommendation in the FAD. Former marketing authorizations are pending in Spain and Italy. We’re continuing the process of establishing pricing and reimbursement in those markets and will evaluate our options for commercialization in those markets in 2013. seekingalpha.com

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