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MWM

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MWM

Re: None

Friday, 04/25/2008 12:27:37 PM

Friday, April 25, 2008 12:27:37 PM

Post# of 38
Interesting 8K here...

Item 8.01 Other Events



On April 24, 2008, we received a formal response from the FDA to our application for pre-market approval to sell ORCEL for the treatment of venous leg ulcers. The FDA’s extensive and detailed letter asked for clarification on a variety of safety, efficacy and statistical issues, and questioned the handling of various aspects of the clinical data. FDA also suggested remedies for the deficiencies that they noted. Provided management can remedy the concerns of the FDA, there seems to exist the possibility of a future approval.


Currently, we do not have the funds that we believe are needed to address the comments in the FDA’s letter. We are considering our various alternatives.

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