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The FDA is totally switching gears over the last six months and approving this drug on the basis of a theory relating to the surrogate marker of amyloid plaques that we, as an advisory committee back in November, were told to not consider, if The FDA allows companies to get drugs approved on the basis of trials that are stopped early, trials that are reanalyzed, that sets a precedent.
Found on CNN 3 years ago
In the majority of cases, I like to think that The FDA makes the right decision, in cases like this, where The FDA makes what I think is the wrong decision, I think that we need to understand better why the decisions were made in this way.
Found on CNN 3 years ago
If The FDA allows companies to get drugs approved on the basis of trials that are stopped early, trials that are reanalyzed, that sets a precedent.
Found on CNN 3 years ago
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