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CardioPharma Prepares for FDA Submission
Date:10/8/2009

WILMINGTON, N.C., Oct. 8 /PRNewswire/ -- CardioPharma is beginning the final funding phase before submitting an NDA for CardiaPill, the world's first patented triple-combination cardiovascular polypill. "The recent news from Kaiser Permanente reinforces that in this cost containment and efficacy oriented healthcare environment, CardiaPill is in the right place at the right time," stated Don Sellers, CardioPharma's Chairman and CEO. "After our recent meeting with the FDA we believe the CardiaPill NDA can be submitted within twelve months following our final round of funding."

"The recently released results of the Kaiser Permanente ALL (aspirin, lisinopril, lovastatin) initiative provide clinical and economic insight into the significant need for effective, low-cost combination cardiovascular products," noted Dr. Carlos Ferrario, Professor of Hypertension and Vascular Diseases at Wake Forest University, an advisor to CardioPharma and other cardiovascular interest groups. "What was even more remarkable," Dr. Ferrario added," is that this study showed positive results in two years, where prior studies viewing agents separately took five years to reach consistently positive results." He added, "This data shows that placing this combination of aspirin, ACE-I or ARB, and Statin in one pill is an idea whose time has arrived, especially given these outcomes."

CardioPharma's own 170,000+ patient data base mirrors the results published by Kaiser Permanente. "We're also delighted with the positive support and guidance of such organizations as the FDA and WHO which recognize the potential of what CardioPharma is doing," added Sellers.

Dr. Frank Snyder, CardioPharma's Chief Medical Officer, noted, "When CardiaPill is approved by the FDA, the implications for global cardiovascular healthcare will be staggering. There is a well recognized unmet need for a cardiovascular product that both simplifies and enhances co
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SOURCE CardioPharma
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