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FDA — Extension of Comment Period for the 503B clinical-need notice (comment period extended to July 30, 2026)

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Marshall and his collaborator, Robin Warren, won the Nobel Prize in Physiology or Medicine "for their discovery of the bacterium Helicobacter Pylori and its role in gastritis and peptic ulcer disease.” With this discovery - and the simultaneous patent expirations on ASD’s - almost overnight, the prescription drugs became an outdated methodology for treatment of ulcers