MichaelPerez
2021-12-14

I got a question regarding EMA marketing authorization process with accelerated assessment timeline. The agenda for CHMP meeting indicates NVAX vaccine stuff is outlined in “list of question” state. I’m searching the EMA marketing authorization process which indicates that this is pretty early stage right after initial assessment. During this session the answers by NVAX for the questions raised from EMA will be assessed and “list of outstanding issues” will be adopted. This is where I’m confused. The massive news from Europe suggested that the approval will mid December but the EMA authorization timeline indicates that this “list of questions” is at day120 out of 210. I know that $Novavax(NVAX)$ NVAX case is under accelerated timeline of day150 for the final decision. Does it mean that further assessment is skipped for final decision? Based on all the information I believe so, but I want to make sure.

免责声明:上述内容仅代表发帖人个人观点,不构成本平台的任何投资建议。

精彩评论

我们需要你的真知灼见来填补这片空白
发表看法