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Saturday, 07/13/2013 11:50:07 AM

Saturday, July 13, 2013 11:50:07 AM

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JL? Vascepa new indication for the prevention of skin cancer?

http://www.ncbi.nlm.nih.gov/pubmed/12771037

Market size is as big as REDUCE-IT.

Skin Cancer Statistics
Skin cancer is the most common form of cancer in the United States. The following statistics refer to melanomas of the skin. Non-epithelial skin cancers, which are not reflected below, represent 7% of skin cancers that are tracked by central cancer registries. These statistics also do not include data for basal cell and squamous cell carcinomas, which are not tracked by central cancer registries.

In 2009 (the most recent year numbers are available)—

•61,646 people in the United States were diagnosed with melanomas of the skin, including 35,436 men and 26,210 women.*†
•9,199 people in the United States died from melanomas of the skin, including 5,992 men and 3,207 women.*†
*Incidence counts cover approximately 90% of the U.S. population; death counts cover approximately 100% of the U.S. population. Use caution when comparing incidence and death counts.

http://www.cdc.gov/cancer/skin/statistics/

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61,646 per year dx for just Melanomas, the most deadly of the skin cancers.

NDA 505b2 could be applied for using NEW "Epideted Programs for Serious Conditions" guidance.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf

Williams

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