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Biotech / Medical : Sepracor-Looks very promising
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To: Biomaven who wrote (9038)11/22/2005 12:59:57 PM
From: Iamarangerboy  Read Replies (1) of 10280
 
I had met with Southwell directly after the Soltara disaster and had also discussed this issue with him.... they hopefully are playing this close to the vest. Does anyone know the submission process of such a combination of 2 already-approved FDA drugs to the FDA .... as an advair.... Is it a whole new process that would require independent efficacy studies.... taking years to get thru or is it a foreshortened process. The group at Sepracor has seemed to always look at the broad economic picture (potential patient population, frequency of usage,chronicity of disease) in deciding which drug to pursue..... I was at a loss as to why an "advair" competitor was not of higher priority.
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