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The New Jerseybased biopharma intends to request a formal meeting with the FDA to further understand the BLA deficiencies and how best to resolve them, Russell Trenary, the companys president and CEO, said in a statement
Notably, researchers observed no similar reduction in hospitalizations unrelated to alcohol in T2D populations and smaller impacts on hospitalizations unrelated to alcohol in populations with obesity, suggesting the effect may be specific to alcohol-related outcomes, rather than confounding by underlying health status or general improvements in health
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