You didn't need a sophisticated algorithm when you went from 200 ADEs to 21,000. So they got to be freaking out. They get a briefing on March 1 that Their [FDA's] algorithm they were using was going to mask and hide the safety signals. Now, I have to believe internally they're going great, you know, Right. Unfortunately, the woman who did it didn't give up. (03:35–10:43)
CLAIM
Asserts that the FDA's algorithm was inadequate for detecting safety signals.
This is an excerpt from a raw transcript. The assertions have not been audited or verified. Tap the video to view the source footage and understand the context.
