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[–]iamonlyoneman[S] 2 insightful - 1 fun2 insightful - 0 fun3 insightful - 1 fun -  (3 children)

Despite these imperfections, the data was included in a preprint study that was posted online in June, again in September in an FDA document and then later that month in a top medical journal – and advisers to the FDA and the CDC said the data should have been shared with them, too.

So . . . only trust the company that stands to get a brazillion dollars' profit, when they give you the rosy-numbers presentation? Cool.

[–]iamonlyoneman[S] 1 insightful - 1 fun1 insightful - 0 fun2 insightful - 1 fun -  (2 children)

an FDA spokesman, told CNN in an email that “the FDA received the preprint less than a day prior to the advisory committee meeting,” and “the information was therefore not provided in an adequate timeframe for it to be included in the agency’s meeting materials, and generally the FDA only discusses data at advisory committee meetings that the agency has had the opportunity to substantively review.”

No SIR. They can NOT be expected to review a paper in one day. It's not reasonable.

[–]Questionable 2 insightful - 2 fun2 insightful - 1 fun3 insightful - 2 fun -  (0 children)

Then they had no choice. They should have advised against. This isn't hard to understand. They were derelict in their duty to reject a recommendation.

[–]jagworms 2 insightful - 1 fun2 insightful - 0 fun3 insightful - 1 fun -  (0 children)

Even so, they approved it, knowing they hadn't read it. They can't really complain that they were tricked, unless there was unseen pressure on them to approve it, when it was plain to see they were unprepared to do so.