Friday, August 3, 2012

Letter from FDA to Wedgewood Pharmacy Regarding Compounded 17P ($KV)

This letter from FDA to Wedgewood Pharmacy is from June 29. The purpose of the letter was to "ensure that Wedgewood Pharmacy is not operating under the misimpression that there is a 'green light' to compound large volumes of copies of Makena."

I hadn't seen it before and the retail bulls have been crowing about it. I don't think there's any great relevance - it seems pretty clear that most of the pharmacies are compounding 17P in accordance with a reasonable interpretation of the law and FDA regs.

As the FDA wrote in support of its motion to dismiss, "[The] exclusivity provision [in the ODA], by its plain language, does not guarantee a drug protection from competition. It applies only to bar FDA from approving certain NDAs, ANDAs, and BLAs. It does not bar FDA from approving another sponsor’s NDA or BLA for the same drug for a different indication, nor does it prevent FDA from approving another sponsor’s NDA or BLA for a different drug for the same indication. This provision makes no mention of compounded drug products."

Last year, KV filed its Q on August 9. I'm really wondering whether they file a Q this year. With the sub notes now trading ~7, it seems much more likely that they file for bankruptcy.

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