You can chalk it up however you want --corruption, bureaucracy, incompetence-- this was a game changer and I could tell from Thero's opening line last night.
Amarin knew that something was up when they did the FOIA request. I am 100% certain that there is a well sponsored campaign by very influential people to detail Amarin.
One can opine how it began (moron at mom's basement) but it spiraled into something huge. Just think, Amarin FOIA'ed FDA for communication with clown Nissen -- does Thero wear a tinfoil hat too?
What is most bothersome to me is not who the perpetrators are (could have been anyone) but the fact that the FDA actually drank the koolaid and may drink it again after November 14.
And this is stunning, it still has not been updated:
Yet, FDA did not want Amarin to PR it. Imagine today, stock tanking and us running around like chickens with heads cut off, guessing for the reason.
Again, at this point it irrelevant to me if its corruption, bureaucracy or incompetence. Walking into AdCom and expecting a fair process would be suicidal. There will be these gotcha questions which will be impossible to answer and Amarin will be ambushed, regardless of how near perfect their data is.
Fact is, the data is not perfect, its 99.99% perfect, but if the FDA wanted to derail Amarin's chances, they could. This could be done with literally any trial.
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