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Starpharma's [SPHRY] Australian shares jumped 16% early Monday after the U.S. FDA granted fast-track status to VivaGel, its investigational new drug for the prevention of HIV. VivaGel's New Drug Application (NDA) will receive Priority Review which has a shorter review time. Under the Fast Track program, portions of the NDA can be submitted to the FDA before the application is completed. This early review is expected to shorten FDA approval times significantly. VivaGel is currently being developed as a vaginal microbicide gel to prevent the transmission of genital herpes and HIV. It was also recently awarded $20 million by a division of the National Institutes of Health (NIH) to accelerate its development. We reiterate our Buy rating on SHPRY and believe the only factor holding back the stock of late has been its anemic trading volume. *************** | ||||||||||||
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