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HD - Of your three scenarios, I'm betting on #3. Nothing will change for AMRN but, to slap FDA on the wrist, they will be admonished not to do this again. Meanwhile, the FDA will be free to continue reeming AMRN.
BB - unacceptable to you and me - Yes! FDA is being asked to "revise and reissue" their guidance (which provides their interpretation of the statutory language). Given the FDA's unrelenting desire to screw Amarin, I gotta believe they will find a way to satisfy Congress and still leave Amarin and us shareholders twisting in the wind.
Hope I'm wrong, just no faith in politicians.
HD - Thanks, I had read this before, just forgotten. It does plant the seeds for some hope, but I'm not gonna hold my breath. It seems the language gives FDA wiggle room to revise their guidance going forward. While I believe it's clear what they did to Amarin was 100% in violation, I doubt anyone in Congress is gonna fall on their sword for a little Irish company.
BB - Thanks
BB - sorry if I've missed this before, but who is Healy? Was he speaking specifically of the AMRN SPA? When did Healy make these remarks?
Kiwi - Thx for the clarification. Happy New Year:)
Kiwi - Are you saying you do, or don't, believe the trial will be stopped early (2015)?
BB - I hope you're really not expecting anything from Congress. Just setting yourself up for a let down.
Totally agree BB. AMRN should jump all over this. The FDA can't keep talking out of both sides of their mouth.
Ajax - I read and respect your posts, along with BB, HD and others. Not necessarily implying this is what you are saying, but if any of the BS the FDA has pulled on AMRN is due to AMRN having offended or pissed off the FDA, then shame on the FDA. The FDA is effectively denying a perfectly safe, effective drug from people whose very lives might otherwise be saved. To do this simply because their nose is bent out of joint is reprehensible at best, downright homicidal at worst.
BB - that's my take. If true, the FDA has really got some nerve. No brains, no ethics, but nerve.
Don't know much about where their feet are planted but, in the case of the FDA, I do know where their heads are planted:)
BB,
What's the time clock on the FDA responding to the CP for reinstatement of the SPA (the one file 12/6/13)?
It's a real tragedy if, in the interest of saving lives, the FDA is unable to rise above whatever caused the contentious relationship with AMRN. Not saying I don't believe it's true, just saying it's a tragic reflection on the FDA.
Maybe they're still harboring a grudge over Pearl Harbor?
A delisting notice from Nasdaq is beginning to appear more likely. If I understand correctly, closing below $1.00 (bid price) for 30 consecutive trading days is what it takes. Well, we've had 11 consecutive days so far with today likely to make 12. As the price continues to fall, the likelihood of getting back to a buck diminishes. So, with a delisting notice all but a given, the question is;
What will AMRN's strategy be to avoid delisting?
I believe they will have 180 days to rectify the situation. From my experience, a reverse split is likely what will happen. I hate reverse splits as, from my experience, the price typically continues to fall.
Probably an incredibly naive question but, what the heck.
In a study like Reduce It, why can't the data be made available as the study progresses? There seems no doubt the FDA is doing everything in its power to kill AMRN. I doubt they would stop at somehow screwing with Reduce It. If we were all privy to the ongoing results, it may help keep the FDA honest.
When were these comments made?
Bio - I like that, "Janet wanted to piss on her kill". The FDA just keeps on pissin. Very well said!
Kiwi - Appreciate the responses and your pointing to the positives. Tough to keep a positive outlook at times. Sometimes I wonder with the way everything has gone down with AMRN (ie., with the FDA), will positive R-IT results ever see the light of day? I mean, it seems the FDA has an agenda here; to prevent at any and all costs, the success of Vascepa.
I don't know, looks to me like the stock is doing its death dance.
BB - If I'm not mistaking the authors appear to be Japanese. The US FDA does not consider them to be part of the human race. So, I don't see how this study helps our cause.
That's the damnable hell of it all. All the evidence points to a successful outcome, Vascepa will save lives. The wildcard here is an inept and/or corrupt government agency. Truly a shame.
Given the inherent incompetency of gov beaurocracy, I'd guess it's #5.
Yep, evidence keeps mounting. Seems everyone is aware of the TG-CVD connection except the FDA. What a useless organization!!
BB - Understatement of the day!!!
JL - thanx for the info. Maybe I'm a little too pessimistic?
Zu - I was encouraged by the article. Thoughtful and thorough. Not sure if I buy into the script projections however. Script growth has been extremely slow (IMHO). Seems to me, if Reduce-It fails, the company is sunk.
Bio - Is this something AMRN could actually do? (Pardon my ignorance, I just don't know how this game is played). Logic tells me AMRN should be able to do whatever they want since they (we shareholders) are paying for Reduce-It. If correct, I say go for it. The one thing we've learned with absolute certainty over the past year is the FDA is just gonna keep fucking us. Even if Reduce-It plays to the end and is a smashing success, the FDA will find some way to fuck us. That said, it is time to go nuclear and do what we gotta do to survive.
Yea, ain't the past 6 yrs been great?
zip - hate to sound negative, but those "canned" responses from FDA don't mean squat. They are nothing more than a standard form letter. I've gotten essentially that identical response to several emails I've sent them.
The same BS response to anything sent to them.
It should say "Please know the FDA is making effort to ass-reem AMRN ..."
Who be this individual?
Seriously doubt its a hint. Too clever for the FDA
Problem is the author's names all look kind of Japanese like to me. Remember, the FDA does not consider the Japanese human form to be the same as ours.
Given the relentless downward pressure on the PPS, I gotta believe a major holder (Camber?) is dumping their holdings.
Good point. In my experience, it's usually the last gasp from a dying company.
JL - Thanks for the response. I hope the Swiss play a better game than I. All the science would point to R-It being a success. That said, can we trust the FDA even at that point? Sure seems they are either ignorant or corrupt. And, I don't believe they are ignorant!
JL - you're one of the posters I regularly follow on this board. Are you sincere in your belief AMRN is worth mor than $4? Like many people, I'm down huge on this stock. Right now, $4 seems like a pipe dream.
Kiwi - I think all of us who lurk on this board have learned a great deal about CVD. Unfortunately, the FD f'n A has regressed in their knowledge of CVD.