Friday, September 08, 2006

Something To Pay Attention To?

Merrill Lynch believes a decision should be reached by the FDA regarding Replidyne’s (NASDAQ: RDYN)Faropenem® approval for acute bacterial sinusitis by or before 20 October. One may be inclined to pay close attention to next Tuesday or Wednesday’s FDA panel review of rival Oscient Pharmaceutical (NASDAQ: OSCI) for Factive® also for the treatment of acute bacterial sinusitis and already approved for pneumonia and bronchitis.

In question next week will be the FDA’s updated guidance for the use of placebo controlled trials for new antibiotics such as Faropenem® and Factive®. If the FDA suggests the necessity of placebo controlled trials for either of the candidates it may negatively impact approval and launch timing. However, Merrill Lynch does not believe that such a trial will be necessary for Faropenem® based upon its safety profile. Replidyne may likely move in some directly or inversely correlated manner to OSCI as soon as the news of the panels decision is released.

Both Merrill Lynch and Cowen & CO. are now covering Replidyne. I have not determined what if any IB relationships may exist between the entities but certainly plan to answer that question.

Nearly 40 million Americans get sinusitis every year, according to the National Institutes of Health, and the U.S. market for treatments is estimated at nearly $6B.

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