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Re: Mellowmood77 post# 207566

Saturday, 08/10/2019 2:01:39 AM

Saturday, August 10, 2019 2:01:39 AM

Post# of 425905

In fact the only thing that makes sense to me after I’ve had this time to think about it is JT decided he wanted more than the original sNDA asked for.


No way. If he changed it late in the game, there is no way that he would be able to say that they aren't expecting an Adcom, as he said 10 days ago. And he would not be so pissed at FDA as he was.

On the other hand, if it truly took FDA 4+ months to realize that they need additional 3 months, then at best, that is unbelievable incompetency and every single person that is involved in decision making needs to be fired. If the issue is label, did they not know 1, 2, 4 months ago what Amarin is requesting?

This is so infuriating. If this was a private company, heads would roll. Sad thing is that many don't even see anything wrong here.
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