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Re: None

Friday, 12/15/2017 7:59:40 AM

Friday, December 15, 2017 7:59:40 AM

Post# of 428989
IMO Amarin should be looking to increase supply chain, I think in 5 years "V" will be OTC and labeled as Vascepa. It could be the perfect poster child for the FDA's new developing program: (This would not happen during R-I 3 years of NME exclusivity)

Broadening Access to Nonprescription Drugs: We are considering innovative action in the nonprescription drug area to expand the scope of drug products that can be made available to consumers without a prescription. We will be proposing to allow certain innovative approaches for demonstrating that a drug product can be used safely and effectively in a nonprescription setting. This will allow some drugs that would otherwise require a prescription to be marketed without a prescription through the use of innovative technologies and other conditions that will ensure appropriate self-selection and/or appropriate actual use of the nonprescription drug product by consumers. Examples of such conditions could include use of self-selection questions on a mobile medical app prior to permitting access to the drug, or other innovative technologies to improve safety. Through use of these types of additional conditions, we hope to create a new paradigm of drug safety with greater flexibility that will benefit patients and public health. We are committed to advancing this new framework to enable a potentially broader selection of nonprescription products for consumers, empowering them to self-treat more common conditions and chronic conditions. This also could help lower costs by increasing the availability of products that would otherwise be available only by prescription.



In the future EPA with be extracted from algae not fish, Amarin should start investment in the area ASAP when cash starts to flow.

BB

Mr. McGee, don't make me angry. You wouldn't like me when I'm angry---David Banner

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