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all true ajax, but does that forgive the fda behavior?
This is a way of telling the market that they think they can make progress on the anchor label without having to provide forward looking statements.
I have seen bonus schedules used many times by companies as a preliminary indication of forward guidance...
I would take this as a positive step forward in getting label expansion.
Coleman should be sheisting bricks these days...
I love you all, but I think some on this board are suffering from intense message board fatigue, based on where the posts have gone recently. I hope we escape with our asses intact on the Type A Hail Mary. That way we could begin to address our collective PTSD...
Rich...
Quote:
I would assume that a whole new set and level of players would be involved in the type "A" meeting. Rescinding the SPA was a very serious move by the FDA and you can be sure it was vetted by the legal beagles within the FDA. I also don't think derailing Amarin was initiated by the likes of Dr. Parks or Dr. Coleman. I believe it came from much higher up the food chain.
If I'm correct, it would stand to reason that any potential resolution would come from further up the food chain. I also doubt that the FDA is going to roll over, given the magnitude of their actions. This wasn't simply a "bad" panel vote. It was set up to be a negative panel vote. That combined with rescinding the SPA required more than a couple of people, several levels of personnel,legal oversight and coordination.
All true but if FDA knows that they will kill patients by not allowing label expansion and if they know this will go to court where they could lose, they may have to compromise....
Yes. FDA seemingly has checkmated themselves by not rescinding this spa on the same day...
More sites = access to more patients w trigs as high as possible.
and on top of that, amrn salesforce can actually talk about the Anchor trial as well, as it was a homerun!
then to convice managed care to pay!
sorry, not trying to complain at all, just trying to be realistic.
jl - how does the company execute an off label sales strategy that does not ruffle fda feathers?
that works.
They key on scripts will be strategy if label is not expanded post the fda meeting. Will Amrn begin an off label sales expansion stratgey. If yes, scripts will begin to climb again.
We know FDA is allowing amrn to distribute jelis in plain white envelope. Im sure they have an off label sales strategy percolating.
Who is gonna prescribe it? How can Davita promote it if its not on label?
Not sure how DaVita gets paid in a partnership w Amrn. Davita paid mostly on the bundle now - i.e. a fixed amount of money per dialysis procedure completed. So they are now motivated to reduce cost per procedure as rev/procedure is fixed.
Yes, this is a great drug for those on dialysis Davita is a service company. V does not have a specific label for T1 diabetics so even though both companies serve the same end users, I just dont see a great fit but Im no expert here, admittedly.
Ajax - those insider sales were under 10b5 and were set well in advance if Marine was approved. I dont see anything wrong w mgt selling some stock under a preplanned strategy if and when they got their first fda approval.
The real stock question is the secondary a few months back at $5.75. Without that, amrn would be in super deep trouble and reduce it would be reduced to zero. This is the real question if mgt had a whiff then...
John,
But isnt this kind of a simplistic wish at this point. I do indeed hope you are right but what you are saying is all AMRN has to do is say : "FDA, all we want is approval for 150-499 and can even state any disassociation w CVEs or risk of CVE population"
clearly we would all take that in a heartbeat as AACE guidelines are clear and trig lowering is definitely sought after by docs.
Would FDA almost destroy this company along the way if that is all they wanted?
If that is the case, then we should get approval. I just cannot believe the FDA would put the company and shareholders through so much pain just to make the point that the label should say nothing at all about outcomes. I think this is your point...
If FDA is saying no health risk for trigs up to 500, then perhaps the AACE should chime in right here and right now w a comment...
At this point, this message board is little more than the self help therapy session of the bookstore. Yes, more tidbits will be posted, bit none of that matters.
On dec 20 we will learn if there is an expanded indication or hope of one
If not, then it's all about getting to reduce it w minimal dilution or vulture partnership.
The drug is great and we are all drunk on that message at this point
That is it.
Maybe just maybe that actual mace line is already falling below the projected one.
This whole thing sux but the outcomes study is going to work. It's just a matter of the company and shareholders holding on. A parter would help.
Yes Ajax. You are right. When smart, skilled people live in their own bubble reinforcing how right that group is and how wrong the great unwashed of the rest of world is, bad things could happen... And did.
At least we can finally get some closure on this. Either be done with it or hold for Reduce IT
Amarin discloses FDA rescinds ANCHOR study special protocol assessment agreement
Tuesday, October 29, 2013 08:35:43 PM (GMT)
Consistent with the discussion at the 16-Oct-13, Endocrinologic and Metabolic Drugs Advisory Committeemeeting at which the Advisory Committee voted to recommend against approval of the proposed label expansion for Vascepa (icosapent ethyl) capsules under the pending supplemental New Drug Application (that seeks to expand Vascepa labeling to include the proposed ANCHOR indication, on 29-Oct-13, Amarin received written notification from the FDA that the FDA has rescinded the ANCHOR study special protocol assessment agreement because the FDA has determined that a substantial scientific issue essential to determining the effectiveness of Vascepa in the studied population was identified after testing began.
Specifically, consistent with discussion at the Advisory Committee meeting, the FDA cited results from the ACCORD-Lipid and AIM-HIGH outcome trials, as well as the publicly presented results from the HPS2-THRIVE outcome trial, which the FDA stated in its 29-Oct-13 notice to Amarin, fail to support the hypothesis that a triglyceride-lowering drug significantly reduces the risk for cardiovascular events among statin-treated patients with mixed dyslipidemia and residually high serum triglyceride levels (200-499 mg/dL).
Thus, the FDA stated that it no longer considers a change in serum triglyceride levels as sufficient to establish the effectiveness of a drug intended to reduce cardiovascular risk in subjects with serum triglyceride levels below 500 mg/dL.
Amarin is working with the FDA to schedule a Type A meeting to discuss with the FDA, as permitted by applicable FDA guidance.
The Prescription Drug User Fee Act goal date for Amarin’s pending sNDA for Vascepa in the ANCHOR indication is December 20, 2013. The FDA could complete its review of the sNDA prior to this date and there can be no assurance that the FDA will complete its review of the sNDA by this date
If indeed FDA is changing their policy, then AMRNs case in upholding the SPA could have just gotten stronger. A broad policy change doesnt hold up nearly as well for them as a reason to renege as does new scientific evidence arising to nullify the SPA.
unfortunately the equity raise shows they had a sniff of this...
Good stuff Speed.
Yes. But balance between length and detail is important in such a letter It's my way. Use it and add to it!
tnx speed...
my letter to dr hamburg and others.
everyone please feel free to use it as is or for inspiration for your own letter.
Dear Dr Hamburg:
I am writing you to express my frustration with what transpired during CDERs October 16th Endocrinologic and Metabolic Drugs Advisory Committee Meeting held to discuss the sNDA for Amarin's Vascepa. Vascepa is already approved for hypertrigliceridemia; the sNDA seeks to expand the indication to mixed dislipidemia taken along with statins, also known as the Anchor indication, named after the sponsor's "Anchor" trial.
In my opinion, the Advisory Committee meeting unfairly and abruptly moved the "goalposts" on the sponsor relative to the Anchor sNDA in violation of a binding SPA with CDER. Amarin's Anchor indication PDUFA is December 20th. I am asking that the Anchor indication be reviewed honestly relative to the binding SPA between FDA and the company.
Likely you are aware of the facts here, but for the sake of completeness here is what has transpired:
Amarin's Anchor trial was run under an SPA with CDER, with primary endpoints being statistically significant reduction in triglicerides combined with w LDL neutrality;
Amarin's Vascepa achieved the trial endpoints robustly with a placebo-like safety profile in 2011;
The only other Anchor SPA requirement prior to sNDA submission was that a CVD outcomes study, Reduce IT, be substantially underway;
Amarin submitted the Anchor sNDA in late January 2013 after achieving 50 percent enrollment in the in Reduce IT outcomes trial;
In April, 2013 Amarin received a very clean Day 74 letter from CDER.
In the late summer, CDER scheduled an Advisory Committee meeting for Oct 16, 2013.
Here is where I believe the "goalposts" were unfairly and arbitrarily moved on the company:
The sole question posed by CDER to the Advisory Committee was
"Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT? Please provide the rationale underlying your recommendation."
Dr Hamburg, Amarin's Anchor trial was never designed as an outcomes trial. The question posed by CDER to the committee asks nothing about whether the sponsor's trial achieved the agreed-upon endpoints safely per the signed SPA. Instead, CDER dramatically shifted the discussion to CVD outcomes, which the trial was never designed to measure in the first place. Anchor and the agreed upon SPA were fundamentally ignored. Anchor's design could no better predict CVD outcomes as it could curing the common cold. In fact, during the meeting itself, there was much confusion among committee members about how the question related to the trial with some members even asking for the question to be changed. Because CDER's question had nothing to do with the Anchor trial and the signed SPA, the committee, in the midst of confusion, was forced to vote No, 9-2 to the above question.
It is clear, that the company did everything asked by CDER and the game was abruptly changed on them. If FDA had indeed decided at some point that the they wanted to invalidate the SPA, which is what is implied by the Adcom question posed, there were multiple opportunities along the way to do so which would have resulted in significantly less harm to the company and shareholders. Some of these opportunities open to CDER to invalidate the SPA included
At the time of the Reduce IT outcomes trial SPA agreement was signed two years ago;
At the time of Anchor sNDA acceptance by CDER in January of this year;
At the Day 74 letter in April of this year.
One could potentially even argue that given that the Adcom question had nothing to do with the SPA and that FDA did not notify the sponsor ahead of committee briefing document submission of the question posed, this change in the "goalposts" is in violation of the SPA itself through non notification to the sponsor of a change in understanding of the science underpinning the trial.
In addition to the Vascepa specific facts and opinion above, the collateral damage if Anchor is denied is clearly far reaching:
Reduced confidence in validity of SPAs as a binding agreements between government and industry, which translates into much less risk taking by industry;
Reduced investor confidence in the supposedly binding SPA process, meaning much less capital available for new drug development;
Continued off-label use of other trigliceride-lowering drugs with less attractive safety profiles versus Vascepa, including Lovaza, fibrates and niacins.
Amarin's Anchor indication PDUFA is December 20th. Please ensure the Anchor indication is reviewed honestly relative to the binding SPA between FDA and the company.
In the interest of full disclosure I am a shareholder in Amarin Corp.
Thank you very much for you time and attention to this matter.
If the sconce changed, fda had plenty of opportunities to change the approval pathway. They did not. They waited to the last possible moment to move the goal posts after the ball was already in flight.
Tragic.
clearly they dont care, im just making the point that there is plenty of ammo out there in any cp...
and this is exactly why fda has left themselves vulnerable to litigation.
aim high had failed by the time they accepted anchor snda. in fact aim high had failed by the time they accepted reduce it spa. fda had numerous chances to change the pathway here but waited until the last of last moments. pure cowardice combined with ineptness.
If FDA wanted to blindside AMRN at Adcom in a way that made sense instead of making themselves look stupid they should have posed the following questions:
Is Vascepa safe
Did Vascepa successfully lower trigs while being non inferior on LDL
and thirdly
Should failure of AIM high have any bearing on approvability of Anchor for lowering Trigs?
Reducing trigs can be done by generic lovaza and even omthera. While Vascepa is clearly better in so many ways, it is apparent at this point that educating America that one "fish oil" is better than another is a herculean task, espeically if generics are cheaper.
GSK should buy AMRN right now, discontinue Lovaza immediately, meaning everyone must start using Vascepa. That way, when Lovaza goes generic there wont be any switching at the pharmacy from branded to generic becuase there wont be a generic Vascepa!
Just sell the biz for $5 for Marine and $15 for CVR if Reduce IT is successful.
yes you can buy it later for reduce it. im just saying that the real value driver for the company all along was indeed reduce it. clearly anchor would mitigate risk but reduce it is what matters
Given that Anchor was a twelve week trial meant to measure trig reduction, the trials ability to reduce CV events was about as relevant as whether the trial could cure blindness. The trial was designed for neither of those outcomes.
Here is another way to think about it...
If AMRN gets Anchor and then Reduce IT fails - unless there are other indications well under way by that point, then the story is fundamentally broken at that point anyway.
So while we are all devastated by bad faith being shown by FDA, it has all the time really been about Reduce IT anyway. The only difference at this point seems to be is that AMRN will trade at $1.50 -$2.00 for the next couple years instead of $15. Reduce IT takes the stock to $30 under either scenario, unless of course there is more dilution...
The only sales AMRN should grow now are ones that drop to the bottom line.
these types of studies that anecdotally point to cardiovascular benefit are why it is imperative to keep reduce it trial going. otherwise this is just another omega 3 in the eyes of the heathcare community.
Zu - do you think if the company decides to sell, they are in a position to negotiate a CVR for Reduce IT?
Not as hard as you think.
The present trial is designed with a 90% power. So you can reduce the event count a good bit and still have reasonable power.
There are a few ways one might do this. In addition to shrinking N, one can tweek when the analysis is done. And one can assign a boatload of alpha to the interium. Or any combination thereof.
I think just halting the trial would be insane, but trying to bring in the end date somewhat seams reasonable.
Makes sense, but FDA has to be amenable, which looks to be getting dicey... A partner could defuse the situation.
I still think the best win win we have is to partner w big Reduce IT milestone or buyout w CVR. Basically that was the endgame anyway...