FDA Letter was real, but the FDA is really reaching ...
The FDA letter was real, the FDA is going far out of its way to pretend they incurred harm. A lot like someone examining each statement someone made and asking "Is it possible for someone to be offended by that" which is very different than hearing something and being offended by it outright.
The FDA states that AEGR is making claims for using Juxtapid for uses other than what it is approved for, which isn't at all what the FDA pretends to "back up" their argument with.
The FDA letter states:
“In these [HoFH] patients, they have a devastating disease. They have a lethal
level of cholesterol, bad cholesterol, which we call LDL, going through their blood
stream. And they're born with this disease and often not diagnosed until 8, 10
years of age when they have a heart attack. If you can imagine a child having a
heart attack at 8, 10, 12 years of age. And then they have another event, usually
about every 18 months, and die by the age of 30. And we’ve found out that we can
lower it significantly with this drug. . . .”
-- "It" clearly referring to LDL levels (because nothing else mentioned as "measurable", only LDL "levels"), but the FDA pretends that "it" is referring to the "decreasing the occurrence of cardiovascular events including heart attacks and strokes" but that isn't what the sentence says.
So the real question is, who is pushing the FDA to go so far out of their way to make trouble for AEGR?
I believe this letter clarifies why CEO Mark Beer recently sold $3.5M of shares in his own company. He goes on CNBC, pumps the stock, and then sells massively in the $90 range knowing that the FDA letter is coming and will knock the stock down. This does not bode well for the future of AEGR.
The competition usually alerts the FDA on these matters. Don't suspect the FDA is spending much time watching CNBC. FastMoney is on after hours, and we all know Fed employees work 9-5 w/ 2 coffee breaks and lunch. So Sanofi turned them onto this. You notice FDA speculates about the usual and everyday promo material. I can assure you, those materials will be in compliance. No company is stupid enough to have sales print materials be off label. The companies have lawyers to assure that does not happen, and management knows the Feds are watching. Beer used carefully chosen words to convey his message. A few were a bit over the top; and those carefully chosen did have a specific intent, but are defensible as not being overtly what the FDA is suggesting.