sobre los cambios en el proceso de fabricaciónya lo dijo stan hace 3 días, los cambios son menoresaqui no hay nada nuevo bajo el sol.. no creo que haya una manipulación porque es una empresa muy pequeña... lo que creo es que hay un exceso de histeria y emocioneshttps://ca.finance.yahoo.com/news/changes-to-novavax-manufacturing-data-were-minor-and-process-related-214254990.html Novavax's (NVAX) submission of new manufacturing data to the FDA on June 3, just days before a vaccine advisory committee recommended its COVID-19 doses for use in adults, was related to minor process changes, according to the company.But the late addition has added to the volume of information the FDA has to sort through before authorization.A report Thursday suggested there would be a delay in the process as a result, pressuring the stock during Thursday's session, but the timeline for Novavax has already detracted from other COVID-19 vaccine approval timelines.However, a spokesperson at Novavax, speaking to Yahoo Finance on background, said that early-on manufacturing struggles and the expectation from prior authorizations, appear to be what is framing the perception of a delay."I do think there's this yardstick by which our process is being measured, that's one to two days, and the FDA is saying, 'we're going to do it when we do it,'" the person said, adding that the FDA has given no indication that there is any concern of an intentional delay in the process.On one hand, there is no urgent demand in the way there was for the three other authorized and approved doses - a point repeatedly made at the FDA advisory meeting this week. Novavax CEO Stanley Erck said as much in a recent interview with Yahoo Finance."I can't predict how long it's going to take the FDA to review the data that they have," he said. "We’ll be bringing product into the U.S. this month and it will go through the normal release process and the assays you have to do," Erck said Wednesday.
