Re:AstraZeneca may have provided incomplete efficacy data NIAID
by refurb on Tuesday March 23, 2021 @11:24AM
(#26556107)
As someone who had been a part of FDA interactions, it’s not being communicated via the media. I have no doubt there were conversations between the FDA and AZ prior to the press release.
I assume that whatever the discussion, it wasn’t going to get resolved quickly so the FDA informed AZ they could not sit on the information and would have to make a public statement.
The actual final data analysis isn’t done (AZ mentioned this in their press release). It sounds like they did an initial analysis of the final data, it looked similar to the Feb interim data, so they said “good enough, go with 79% in the press release” and the FDA was like “wait a second, that wasn’t the agreed upon final data”.
I assume that whatever the discussion, it wasn’t going to get resolved quickly so the FDA informed AZ they could not sit on the information and would have to make a public statement.
The actual final data analysis isn’t done (AZ mentioned this in their press release). It sounds like they did an initial analysis of the final data, it looked similar to the Feb interim data, so they said “good enough, go with 79% in the press release” and the FDA was like “wait a second, that wasn’t the agreed upon final data”.