It reminds me of a biotech stock with everything hinging on FDA approval of its single product.

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The FDA reviewers said a single study could be performed that would address all the major issues raised by the review.

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Later the same year, the FDA approved Teva's single-pill Plan B formulation and allowed it to be sold without a prescription to women age 17 and older.

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If the FDA can point to a single contaminated piece of farmland and explain what went wrong, it will go a long way toward ensuring that the spinach is safe in the future.

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"The abuse ratio for oxycodone combination products was 24 emergency department visits per million tablets dispensed, compared with 85 visits for oxycodone single-entity ER products, " the FDA reviewers said in the documents.

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Aside from restrictions placed on it by the FDA (for instance, it will be sold only through a single mail order pharmacy), the drug causes the buildup of fat in the liver, a warning sign that it may also cause liver damage.

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The FDA based its approval of the NovoTTF 100A System on results from a single international clinical study in 237 patients with recurrent GBM or with GBM that hadn't responded to traditional therapy.

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The FDA also gave Byetta an "approvable letter" for its use as a single-agent therapy.

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Its purpose is to incubate single-product firms and sell them to a larger medical-device company to get the product through FDA approval.

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