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Re: deadjim post# 5314

Friday, 01/19/2018 9:08:20 AM

Friday, January 19, 2018 9:08:20 AM

Post# of 8608
Novavax provided an update on the status of its Phase 3 Respiratory Syncytial Virus vaccine for Infants Via Maternal Immunization clinical trial, dubbed the "Prepare" trial. Novavax pointed out that an informational analysis was performed in the fourth quarter of 2017, and targeted an efficacy threshold against the primary endpoint at day 90 of more than 40%. In December, the Data Safety Monitoring Board statistician performed an unblinded analysis and communicated that the RSV F vaccine "successfully met" the criteria, the company highlighted in the slides. Importantly, Novavax stated that the informational analysis indicated that its RSV F Vaccine is efficacious, and that Phase 3 enrollment should yield pivotal efficacy data by the fourth quarter of 2018 and the first quarter of 2019. The company expects it to be the first licensed RSV vaccine, with an estimated global peak revenue of over $1.5B.

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