Company to submit NDA within twelve months following the final round of funding
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CardioPharma is beginning the final funding phase before submitting an NDA for CardiaPill, the world’s first patented triple-combination cardiovascular polypill.
Reportedly, CardioPharma collected data on thousands of patients and built a regulatory strategy with the guidance of the FDA to enable the product to be registered first in the US and then to be registered and distributed globally.
Don Sellers, chairman and CEO at CardioPharma, said: “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. After our recent meeting with the FDA we believe the CardiaPill NDA can be submitted within twelve months following our final round of funding. 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.
“We all can recognise the need for a combination drug that data now suggests can reduce cardiovascular events by more than 60%, but we also had to make CardiaPill profitable. We are not building an expensive product, but rather a single, daily dose pill containing a group of gold standard proven generics with the added benefit of reducing issues with what many claim to be one of the biggest problems in medicine: compliance.”
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