The FDA Letter goes quite a bit beyond what was said, and just starts making up stuff about what the CEO said. The FDA Letter states:
"Furthermore, the statements made regarding Juxtapid misleadingly suggest that
Juxtapid is safe and effective as a monotherapy"
Yet nothing the CEO said would indicate Juxtapid as a monotherapy. The FDA is going far out on a limb by pretending that was what the CEO said, and this will **BACKFIRE** on the FDA.
More to come, stay tuned, as this will prove to be a significant boomerang against the FDA.
In the end, it will set a precedent that the FDA isn't treating AEGR fairly, and will serve as a shield against any action by the FDA against AEGR in the future.