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Politics : Ask Michael Burke -- Ignore unavailable to you. Want to Upgrade?

To: ild who wrote (96163)	6/17/2002 12:42:30 PM
From: Michael Bakunin	Respond to of 132070

PR hit briefing.com's in-play page, which may account for the extremely hard pop. I expect the stock to see-saw 'til the Briefing Effect wears off. The important kernel is at the end of the release: The Company understands from discussions with the FDA that one reason for the change in the regulatory status of EECP for the treatment of congestive heart failure was the result of the agency's reassessment of the system's safety profile. This latest decision reverses a June 2000 determination by the FDA that use of the EECP device for the treatment of congestive heart failure would require an approved Pre-Market Approval (PMA), a more rigorous and time consuming testing standard than that required for a 510(k) clearance, before marketing. Given the data we've already seen, there was never much question that EECP had beneficial effects on CHF. Now they can market for the indication without spending any more money. -mb