Tuesday, January 29, 2008

Replidyne: New FDA Warning Letter

***1/30 POST UPDATE*** Here is a link to the letter from the FDA, click (here) to read.

There is not really too much to go on here, but …an FDA warning letter was recently issued relative to the antibiotic faropenem and the company filed an 8K with the SEC yesterday.

"On January 22, 2008, Replidyne, Inc. (the "Company") received a Warning Letter (the "Letter") from the U.S. Food and Drug Administration (the "FDA") pursuant to the completion of the FDA's review of clinical trials performed in connection with the December 2005 new drug application ("NDA") filed by the Company in support of faropenem medoxomil 300 mg tablets twice per day dose, in respect of which the FDA issued a non-approvable letter in October 2006. The clinical trials that supported this NDA were conducted by Bayer Corporation as a previous licensee of faropenem medoxomil. The Company intends to respond timely to the issues raised by the FDA."
Faropenem, is a novel oral community antibiotic, which may be used as a first-line antibiotic. Faropenem is in late stage clinical development in adult patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and community-acquired pneumonia.

Interestingly when I went to look at how the Replidyne share price (NASDAQ: RDYN) was responding the thought was that the chart was going to look akin to a fall off a cliff however, at the open the stock is trading in the green. Hmmm…Can’t quite figure this one out? Does anyone have any thoughts on this letter or Redplidyne as a whole? Please leave a comment at the bottom of this post.

***Update*** It is the homestretch for the CLSDF Readers Company of the Year Award. ONLY TWO DAYS REMAIN TO CAST YOUR BALLOT! Voting ends on 31 January.

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