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Wonder if this was what Amarin’s FOIAs were about?
Make it 100% and we’re good.
The company supposedly hired top notch consultants to help guide them through the EU approval process. If these crackerjack consultants didn’t know Vascepa wasn’t eligible for expedited review, does that say more about them or the people who hired them?
How about those fatal side effects?
Or she could actually be out of the office with no email access until tonight.
Did you not learn grammar and spelling in grade school?
More like brown acid.
Thero updated guidance after Q2 as part of the company’s effort to pump the stock price in advance of the latest dilution.
It’s a good dress rehearsal for the AdComm.
Is that the full text of his response?
“I have no idea what I would do with free time if I wasn't plotting FDA demise”
Make cheese curds?
Punching the playground bully in the nose is frowned on here!
Have you ever seen a bureaucrat shuffle paper? It takes time.
The only funny part is that he's using Kiwi's Kaiser rant as evidence that the big insurance companies aren't on board with the Reduce It results.
Those read like the first two sentences in your soon to be written autobiography!
Cringeworthy sign of insecurity. No wonder the fish don’t fear you.
They/he/it is starting to sound like BB.
How much time have you spent watching Carlson?
You can buy it now for $3,500 if you act fast. Otherwise, he/it/they are going to reduce the price to $35!
So, you’re saying it’s “unlikely” at this point?
Weren’t they aware of the labeling request on 3/29 when it was submitted?
CRL....Fear mongering!
Boilerplate
And how long would the appeal process drag on?
If I could figure it out, surely a smart guy like you can. It’s not rocket surgery!
You do realize who this guy is, don’t you?
You must not own any stock!
Cletus
How would Chen know?
Tailgate?
Does it concern you that Amarin hasn’t launched a more aggressive defense of the MO issue if they have any significant doubts?
He also thought it was unlikely they would have an ADCOM.
What recent lawsuit?
It would be nice for management to be a little more forthcoming about the inquiries they have received from the FDA.
Would you feel better if they sent you an FDA ball cap?
When Thero said label negotiations start about a month before PDUFA date, was he signaling that at that point approval is in the bag (assuming they don’t pull some bull headed JZ stuff) and will that point be revealed? Asking for MRC.
And there are other stocks that are down more than 6% in that same time frame.
How many times has the FDA granted priority review only to rescind it during the review process by, essentially, extending the PDUFA date? I trust you have the citations at hand.
Ever hear of General Custer?
I think Mike Rowe would be a better choice, but I doubt even he would want to get involved in a job that dirty!