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CT

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CT

Re: None

Thursday, 05/28/2009 4:52:03 PM

Thursday, May 28, 2009 4:52:03 PM

Post# of 252400
Need expertise. I've been shown a business plan for a company that wants to develop and market a device that provides "safe" access to the pericardial cavity. Aside from the technical details, the plan calls for clinical trials to start 4Q09 and FDA approval by 4Q10. Can anyone tell me roughly what kind of clinical trial requirements there are for medical devices. Their timeline seems overly optimistic.
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