Moderna will file for emergency use authorization of corona vaccine in US and EU

https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-primary-efficacy-analysis-phase-3-cove-study

by mrleiter • 6 years ago

5 3 6 years ago

investors.modernatx.com

refurb2• 6 years ago

So Pfizer/BioNTech’s FDA advisory committee meeting is slated for Dec 10th and Moderna’s a week later, Dec 17th.

For folks that are interested, advisory committee meeting slides are typically posted on the FDA website ahead of the meeting, though it might be after considering the timelines. They tend to be 200+ slides decks that are dense with data and key regulatory discussions. Great if you want to get into the details.

lbeltrame• 6 years ago

According to the docket[1], materials to be discussed will be posted 2 days before the meeting. The meeting itself will be also streamed.

[1] https://www.regulations.gov/docket?D=FDA-2020-N-1898

refurb2• 6 years ago

Nice! I knew someone in HN would know the details.

Edit: Details on the FDA website

The online web conference meeting will be available at the following: https://youtu.be/owveMJBTc2I

https://twitter.com/US_FDA (Supported in Chrome browser)

https://fda.yorkcast.com/webcast/Play/d75d80a3eb6e419986181c...

Moderna will file for emergency use authorization of corona vaccine in US and EU

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