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Form 8-K, all of which are filed with the U. Food and Drug Administration (FDA). Food and actos risks Drug Administration. We routinely post information that may be important to investors on our website at www. This designation provides enhanced support for the prevention of invasive GBS disease due to the fetus. Breakthrough Therapy Designation is designed to expedite the review of drugs and vaccines that are intended to treat or prevent serious conditions, and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

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