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And penicillin is just a fungus!
Right D.F.?
My opinion about these advisory committees….
They should be non-voting, period! I'm fine with the FDA assembling a bunch of experts (even if they're "so-called experts") to discuss and debate a drug at any point in the approval process, but when you turn it into a voting situation you are not only absolving the FDA staff of having to do the work they were hired to do, but you are clearly opening the voting members up to outside pressures to vote one way or the other. Just my opinion - and BP didn't pay me to post this.
Convince us that the pathway doesn't exist!
And show your work, please.
I sent the company an email a couple of days ago
asking this question. When (if) I get a response, I'll post it.
Any idea how long it takes for NASDAQ to approve the filing to uplist?
Be the 10th person to post that the FDA's decision
has been delayed and win an all expense paid tour of the FDA headquarters hosted by the good doctor Colman!
If, by some miracle the FDA approves the sNDA for Anchor
and those bonuses were earned, it could be argued that Thero is not entitled because he is now the president and CEO (just as Joe Z. Was excluded when he was in that position). And there would be shareholders banging on their high chairs about it. So, it's the prudent thing for the BOD to clear this up before the FDA takes any action. And extending the deadline in the bigger scheme of things is not unreasonable.
They haven't scheduled a cc to discuss
the results......yet!
Who paid Crowell & Moring to file the CP?
That's the real mystery here.
In the press release regarding the SPA for
the Reduce-It Study, Joe Z. Stated that the Reduce-It indication would be twice as big as the Marine and Anchor indications combined, but only mentioned diabetics. So maybe somewhere in that Reduce-It market they also see dry eyes and other treatable problems.
2013 will finally be over for Amarin!
And hopefully a much better 2014 will unfold.
BioChica... You're going to end up in timeout with Phil Robertson with talk like that!
Now run over to the 7-11 and apologize to those guys.
Merry Christmas, David!
3, 2, 1.....crickets!
You need to study the history of this company
It's had more lives than Morris the Cat! Cease to exist, it will not.
Dude, put down the egg nog!
It must just be you.....my shares are
are holding steady at not a penny less than $30 a share!
More like tens of millions....
And that's not including all the staffing requirements it takes to deal with all the paperwork. I know it sounds so easy sitting here pecking away at a keyboard, but you really need to experience federal bureaucracy firsthand.
It takes money to file and process these applications!
So, they probably put their money where they thought they'd get the biggest bang for their buck. Of course it doesn't cost anything to second guess their decisions.
Hopefully, a day that will NOT live in infamy!
What gets me...
Is that there was plenty of reason to over prepare, especially once the briefing documents were released. I would have at least cancelled the post Adcomm cc Champagne order.
Jefferies and Citigroup still holding...
Or did they dump?
You mean, so far?
You are just the kind of voter the establishment loves
Democrat or Republican. Go along to get along!
I prefer standing on principle, even if that means losing an election or a battle with the bureaucrats.
I want to know if Amarin knew the wording in advance….
Was the question that was put in the commission members packets exactly what was distributed to Amarin in the briefing document? If so, then someone at Amarin should be called out. Had they had the presence of mind(s?) to go through the documents with a fine tooth comb and discover that the wording was problematic, they would have contacted the FDA in advance of the meeting to either change it or request a postponement of the meeting (if that was possible).
I've spent most of my working career in real estate development and have been involved in the processing of hundreds of zoning/land use applications. Routine procedure is to get the staff report as soon as possible before the public hearing to see if the staff is going to recommend approval, denial or approval with conditions. And you always try to work with staff to iron out any issues so you aren't out there on the floor in front of the public arguing over stupid stuff. And if you can't work it out ahead of time, you ask for a continuation. I can't imagine that this process with the FDA is any different and that if Amarin had made that attempt (to change the wording or request a continuation) they would at least have had that on record supporting the argument here that the FDA was not willing to work with them.
So, in other words Aqua, what you're saying is….
buy low and sell high? And if it don't go up, don't buy it? Finally, some advice worth taking!
Atlas....
Good to see you back!
All the money they're saving on cutting
Sales staff is being wasted on SR! It would be nice to hear them justify his hire during the cc.
But what if we wait until 2016 and....
Reduce-It fails to produce the results or the FDA finds some reason to reject them (assuming interim results haven't already done the same thing)? There obviously is a serious trust issue with management at this point and I think they'll have a hard time convincing anyone (shareholders, BOD, potential partners or buyout companies) that they actually have a valuable project. I don't mind sitting on shares until 2016, but I need to be convinced that it will be worth the wait!
Especially on a day when the jobs data is really bad!
Approve Keystone XL and Anchor and put people back to work, Mr. President!
Like Lucy and Ethel we have
Raw box and Brig88!
Who paid Crowell & Moring to file the citizen petition?
Probably because they are in the window of releasing quarterly results.
Somebody needs to call Jack Bauer.....
Maybe we need the NSC to connect the dots here - at least for me - because I don't understand how the FDA would change the OB so that the active ingredient in Vascepa is also the active ingredient in Lovaza. Wouldn't this change the formulation of Lovaza and require it to go through a whole new approval process with the FDA? Doesn't Vascepa have sufficient patent protection to prevent Lovaza from utilizing its active ingredient?
You also said that Amarin has been told to shut up and take it. Take what? Have they objected to this so called citizen petition? What are the consequences for them if they don't shut up?
Sorry for all the questions (actually I have a bunch more based on your postings today), but this is the first time I've seen anybody post such strongly worded accusations against the FDA and all the other players you mentioned.
Anyone here?
I probably wouldn't admit
that I had experience stealing candy from a baby!
Help me out here. I just read the entire 11 page Citi report and
I didn't see the word "pathetic" used to describe script numbers or anything else the company is doing. So, can we tone down the hyperbole?
Rawnoc.....
Was that necessary?
Hello? Anybody still here?
Garneau on the offer to buy Fibrek:
"Since we announced our offer late in November, Fibrek has found time to adopt the tactical poison pill and enhance compensation packages for senior management, but has yet to provide its shareholders with a competitive alternative to our offer. Shareholders must now be given the opportunity to decide for themselves whether or not to accept our offer."
Amazing how his interest in shareholders' interest has changed.