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BrainStorm filed the BLA using the FDAs File Over Protest procedure after the regulator issued a Refuse to File letter in November 2022

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r/ibs Gut Healing Reports Irritable Bowel Syndrome Users with IBS frequently report: Reduced bloating and discomfort Improved bowel regularity Decreased food sensitivities Better tolerance of previously problematic foods NSAID Damage Recovery A common theme involves recovery from NSAID-induced damage: Resolution of NSAID-induced gastritis Improved tolerance after chronic NSAID use Healing after GI bleeding events "Leaky Gut" Experiences Many users report improvements in suspected intestinal permeability issues: Reduced systemic inflammation markers Improved food tolerance Better energy levels Reduced joint pain (potentially related to gut-joint axis) Oral vs