NeuroVive's IND for Clinical Development of NeuroSTAT Approved by FDA
ABLIVA AB (NEVPF)
NASDAQ:AMEX Investor Relations:
neurovive.com/investor
Company Research
Source: PR Newswire
LUND, Sweden, May 10, 2019 /PRNewswire/ -- NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX: NEVPF) today announced that the US Food and Drug Administration, FDA, has approved NeuroVive's IND (Investigational New Drug) application, enabling clinical studies in the US with the company's drug candidate NeuroSTAT in development for treatment of moderate to severe traumatic brain injury, TBI.In the US, an FDA approved IND application is needed in order for not yet marketed investigational drugs to be used in clinical studies. The application has to contain detailed information about pharmacology and toxicology studies, manufacturing information, protocols for proposed clinical studies and information on the qualifications of the clinical investigators, to assure that research subjects will not be subjected to unreasonable risk."We're truly excited about the approved IND, which is also NeuroVive's first. It's a highly important milestone and a great recognition for the project, a
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