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Stock impact report

NeuroVive's NeuroSTAT Project Receives FDA Fast Track Designation

ABLIVA AB (NEVPF) 
NASDAQ:AMEX Investor Relations: neurovive.com/investor
Company Research Source: PR Newswire
LUND, Sweden, July 27, 2019 /PRNewswire/ -- NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX: NEVPF) today announced that the company's candidate drug NeuroSTAT, in development for treatment of moderate to severe traumatic brain injury, TBI, has received Fast Track designation from the US Food and Drug Administration, FDA, facilitating its clinical development and path forwards to market.NeuroSTAT's FDA Fast Track designation makes NeuroVive eligible, for example, for more frequent meetings and written communication with the FDA, continuous feedback on each section of its New Drug Application, NDA (for sale and marketing in the US), as well as the possibility to have its NDA reviewed within a shorter timeframe. Fast Track designated drugs address unmet medical needs in serious conditions, and the process is designed to facilitate accelerated drug development and, ultimately, to get new drugs to patients faster.NeuroSTAT protects and stabilizes mitochondria and is in developm Show less Read more
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