Muchas gracias , Seguidor.
MTSL Issue 817 - 17 Diciembre
http://www.bioinvest.com/wp-content/uploads/2015/12/MTSL-Issue-817.pdf
ALKS, ANTH, MDCO, NKTR, NVAX, OGXI, PCRX, SGMO, ZIOP
NVAX – Begins Phase III Maternal Trial Early – RESOLVE Trial Enrollment Complete
The first subject in the registration maternal trials for the RSV vaccine was announced last week, somewhat earlier than the Q1:16 forecast (https://clinicaltrials.gov/ct2/show/NCT02624947?term=Novavax+maternal&rank=1). The collaborator is The Bill and Melinda Gates Foundation, which awarded NVAX $89 million in funding for this trial back in September when the initial positive results were released. While the trial is expected to take 2-4 years to be completed, a big window depending on the pace of enrollment of the roughly 5,000-8,000 pregnant women, the rapid regulatory and clinical turnaround from a small Phase II 50-person (~28 on vaccine) trial is testimony to both the strong regulatory support for this vaccine and astute management execution.
Even more importantly, the Phase IIIRESOLVE trial of the RSV vaccine in the elderly has completed full enrollment of roughly 11,850 subjects at over 60 centers worldwide in just 35 days (https://clinicaltrials.gov/ct2/show/NCT02608502?term=Novavax+RSV+vaccine+elderly&rank=1) – one more example of management’s focus and execution on this soon-to-be first ever RSV vaccine. In early 2016, the Company is due to reveal strategies on three areas of company development: a) Novavax‘s quadrivalent flu vaccine; b) the disruptive quadrivalent flu/RSV combo (‘respiratory’) vaccine, and c) the RSV vaccine for pediatrics (ages 2-6). While the end prize seems far away in this stock market, NVAX continues to move as fast as possible with its breakthrough program, with Phase III data in the elderly in H2:16 and an FDA application filing and approval soon thereafter. 2015 has been the most de-risking and value added year in the Company’s history by a huge margin.
NVAX is a BUY under 15 with a TARGET PRICE of 20