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Where Its ApprovedAnd Why Not in the US Cerebrolysin is approved for treating stroke, traumatic brain injury, and/or dementia in Austria, Germany, Russia, China, South Korea, and approximately 50 other countries across Europe and Asia
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
They dont manufacture one out of thin air
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