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Absolutely agree Chica! Thanks JL for a plain English explanation to the BS technical SEC release that left everyone in a panic and the shares in a free fall. If AMRN management cared AT ALL ABOUT SH they would have provided that explanation PM and prevented the crash.
I honestly think JT wants the co to appear on the verge of bankruptcy because he thinks it will help pressure FDA to compromise on A to save R-it.
FDA recent move to remove TG 200-500 data off L label shows they are reinforcing there position the TG <500 don't require Tx and indicate no compromise at all is coming from any level of appeal.
As I understand it the middle ground they are talking about would be to allow the reps to use the anchor data in promotional material and discussions with Drs even though they would not have the indication.
Thanks Biwatch! This is very helpful
What about news on the combination with metformin and the new direction in diabetes?
I agree Zip. They will approve A when we get positive R-it results (which I feel confident we will get). I should have said "they will never reinstate the SPA during the appeals process."
I, like many, had been hoping for a compromise on A during the appeals process but came to accept that the FDA won't approve a drug for lowering TG because they agree it's a good anti inflammatory.
AK
The hole problem is exactly as you stated: Eicosapentaenoic acid restrains the development of the cardiovascular events independent of triglyceride. The point being "independent of triglycerides"
AMRN has applied for the indication of lowering triglycerides but the evidence points to the benefits of V having nothing to do with lowering triglycerides. Evidence points to the anti-inflammatory actions has being the cause of the benefits. I think the FDA has made it very clear they are never going to approve the anchor indication because triglycerides are not the problem. I also think that that message was the reason for the shift to a combination with metformin for the treatment of diabetes. The question now becomes how long will it take before they can get approval for a different indication
JL
I completely agree with your hypothesis that the root cause of the beneficial effects of Vascepa being it's anti-inflammatory actions and not TG lowering. With this in mind is it an option and if so what is the procedure if AMRN wanted to abandon (or at least deemphasize) the lowering TG indication and try an anti-inflammatory indication. I suspect there wouldn't be a CVOT requirement and safety data is already accepted as well as data on lowering inflammatory biomarkers. What would be needed to move forward and what type of timeline would they be looking at?
TIA
I believe Kowa starts at the end of May so things will continue to be quiet for a while yet.
Does that also potentially mean With the legal firepower of Pfizer, Amarin patents can be readily defeated if they chose to force EPANOVA????
I completely agree with you Ziploc. Not just hard to prove but easy to defend if viewed from the perspective of Eric Colman. I disagree with all the conspiracy theories. I think Coleman reviewed three CVOT studies all of which failed to support the long-standing hypothesis that lowing TG reduced CVD (yes I know, Pts had normal TG levels, I said failed to support not proved incorrect). After millions of patients spent hundreds of millions of dollars and endured side effects all with no benefit he simply decided before any more products come on the market he wanted some proof - any proof. SPA was based on the assumption lowering triglycerides lowered CVD. No one questions there is a correlation but there is no cause effect connection. As many on this board speculate the true cause may be an inflammatory reaction (nod to JL) and triglycerides simply a byproduct. IMHO positive subgroup analysis of the thrive data will provide that proof. Since the FDA used the thrive data to support rescinding the SPA they will have no choice but to reinstate it if the subgroup data proves a connection. That single article could be a game changer for Amarin and it is due out at any time. If the data is neutral or negative it will not help V but the inflammatory theory remains unchanged.
Just my 2 cents
Ps: sick of all the BO talk on ST. Is it just me or would you have to be an idiot to sell the company when the SP is near record low and the company is at its weakest while having plenty of cash for another 2 yrs?????
JELIS would not be allowed under those rules
In the guidance document it mentions the appeals court struck down the first amendment argument for using unapproved information when promoting a drug. Why would you think Amarin would have any success going that route?
Chance of a complete reversal and admission of being wrong is probably zero but a face-saving compromise is very high
You forgot to mention in your boxing analogy that the referee in the ring is the undefeated champion's coach.
I read a post on this board or Yahoo about a month ago from someone who appears good at statistics and their estimate was that if the results were as good as the JELIS trial we would have results in early 2015 -best case scenario.
There is no benevolent purpose for AMRN to complete reduce it. AMRN is doing it because a positive result will result in a blockbuster drug bringing in billions of dollars. Don't kid yourself. We are all in it for the profit. End R-it now and this stock has a top end value of $4-$5. If it becomes the first non-Statin proven to reduce cardiovascular disease it could still be a $30 stock eventually.
The positive results could be a result of triglyceride lowering or it could be the result of its anti-inflammatory action. This uncertainty would mean reduce it results could not be used by other non-Statin drugs to claim reduction in cardiovascular disease. Vascepa would reign supreme for at least a decade
Well done
I think the vote would have gone the same way but GSK would have been given the heads up that outcome data was needed and SPA would never have been rescinded. FDA would be openly supportive and conciliatory to work out a compromise. IMO
A new dose for an existing drug and already approved indication would be pretty close to a rubber stamp. Considering the AHA just told physicians to "abandon fibrates" makes it even more ridiculous.
Change in policy to evidence based medicine ???
Dismissed it because it was primarily only female Japanese patients which are considered to have SOME distinct pharmacokinetics. I don't mean it in any racial way, only as a fact that they have some unique metabolic processes. If any US company wants to enter the Japan market they have to do trials on Japanese pts before it will be approved. Maybe a bit of bitterness involved as well
sorry, previous post meant in reply to go seek not Labner
Labner
I really like the quotes you took from the Adcomm. The one that jumped out at me the most was when Colman said "EVEN if we approve V". If he was considering approving V he would have said "if we approve". The "even if" certainly emplies that it would be an exceptional act.
Another important part was when the panel asked what would happen if V was approved and reduce it turned out negative. FDA replied they would need to have the company voluntarily withdraw the drug otherwise it would go to the lawyers and became a long and messy process. When the chairman described his reason for voting yes he said unlike the other panel members I am not basing my vote on what the FDA would do if R-it is negative. The FDA can approve a drug but it appears very difficult to unapprove a drug. This is why they are so adamant about waiting for CVOT data.
I guess it would have been more accurate to say what is the point of arguing LDL when Colman has stated that the FDA accepts LDL as a biomarker when he replied to the reason for not requiring CVOT for PSK90 drugs.
I do agree with you on all your comments about the funding and finances around BP but I suspect we differ on the scope and size.
I know we will never know the whole story behind what has happened. I just don't want people to get false hope on December 20 like many, myself included, got our hopes up on October 16 only to have the shorts come in for the kill.
V has great potential for cardiovascular disease as well as an anti-inflammatory for conditions such as diabetes, arthritis, etc but we are years away from an indication for any of those.
V lowers LDL in a statically significant way but not in a clinically significant way (6% or so if memory serves). You won't get an indication for lower CVD by lowering LDL by 6%. V is for lowering TG. It has huge potential for its anti inflammatory actions as well but that will need specific trials as well but may open another equally large pt population (thinking diabetes, arthritis, autoimmune disorders etc). I am just as excited about anti inflammatory potential as TG but we are years away from those indications being approved
Your discussing trials from 8-10 years ago so I don't see how that applies to the FDA making a policy shift within the last year. AHA believes in statins and I don't see the FDA telling them they are wrong and trying to get them to change their guidance. So they leave LDL in as an accepted biomarker. I don't believe in conspiracy theories and saying AMRN got mugged. I think they got screwed by the timing of the new policy. I'm looking to rationally explain the bizarre decisions of the FDA in the last year. You don't have to agree with me, I'm just putting out a theory for investors to consider.
Policy is not retroactive. I believe they will use EBM on assessing NDA going forward and it is the responsibility of AHA and other such groups to giving prescribing guidance. AHA said in Texas to abandon fibrates and niacin.
PSK90 drugs lower LDL a biomarker which has already been proven to lower mortality.
I don't agree at all with what they did or how they did it either. I'm just trying to point out that if you interpret what has happened as a policy shift to EBM then everything makes more sense (not condoning) and people can stop investing based on just the science. Science wise this should be a no brainer - safe, effective, side effect profile comparable to placebo - it doesn't get any better. People seem to be searching for an explanation as to why this slam dunk has completely abandoned rational thinking.
The FDA may throw AMRN a bone on Dec 20 and say that it can be used for Diabetics or other non-cardiovascular indications but that is a long shot.
I forgot to mention that the "controversial" new recommendations from the AHA is PURE EBM. Only recommending statins that have been proven to lower mortality. I think the AHA gave the FDA the heads up a year ago that is how they were moving and so the FDA cardiovascular division followed the AHA.
AMRN is getting screwed here because of the timing of their sNDA and the policy shift so the FDA may feel more open to a compromise. The problem is that if they compromise for V then they will have to do it for the other omega 3's coming as well.
I invested based purely on the science and got burned. Figured out what is going on and I'm just trying to give others food for thought.
good luck longs
Evidence Based Medicine
Back in the 90's over prescribing concerns lead to a grassroots type organization promoting Evidence Based Medicine (EBM). The bottom line for EBM is that if you don't have absolute proof of a reduction in mortality or morbidity then the drug should not be prescribed. For example, if you can absolutely prove you can lower a biomarker (eg: Triglycerides) but lowering that biomarker is only assumed to reduce morbidity or mortality then you should not prescribe it.
I don't think what has happened to AMRN has anything to do with BP, politics, hatred for JZ, etc. I think a year ago the cardiovascular division of the FDA made a policy shift to EBM. I don't think AF is clairvoyant or a criminal on the take from BP or FDA, I think he just became aware of how vigorously the FDA was going to be about their new policy shift.
I fully agree that the AIM and ACCORD trials deal with different pt populations (TG around 200, not 200 - 500) and shouldn't be used as an indicator of V's potential. I think IMHO that the FDA is using them to support their policy shift. AIM and ACCORD showed that prescribing based on biomarkers (reducing TG, raising HDL) resulted in decades of drugs with significant side effects being prescribed to millions of patients with no clinical benefit. This is their justification for rescinding the SPA - more a change in policy than a "significant change in science" required to so something as drastic as braking a legal agreement.
Looking to Dec 20th, I see NO reason to suspect any change in policy or treatment and fully expect a complete rejection which i feel is already built into the current pps.
I have researched the science behind V and fully believe R-it will be positive and this drug will be a huge moneymaker eventually. The JELIS study was immediately blown off by the adcomm because it dealt with too narrow of a pt population and Japanese are known to have some unique pharmacokinetics (the Japanese equivalent to the FDA requires trials on Japanese people before any access to their market). IMO the R-it study should have very comparable results. Someone good at statistics posted that JELIS like results would make the preliminary results available by the end of 2014.
I'm a pharmacist who worked on contract with Eisai and Schering Pharmaceuticals doing NDA submissions so I don't know crap about statistics, company valuations or how revenue predicts pps but an FDA approved drug with an inferior competitor who brings in a billion a year being valued at about the same as cash on hand sounds a little ridiculous.
FDA = bureaucracy = slow and policy/procedure driven. Based on their current policies they have no reason to accept A. In fact they may say the SPA allowed the sNDA for A and now that the SPA is gone so is AMRN's right to apply for A. FDA took 3 weeks just to deny their request for a meeting so by the time they do agree and find a time that everyone is available we are in to Feb. I took the company's bonus announcement as a subtle way of telling shareholders not to expect anything until March to June 30th (but I'm not clairvoyant either)
Good luck to all longs
Should have just stated that the newest AHA guidelines recommend "abandoning fibrates" as they have shown no clinical benefit
Only 40 Pts will be enrolled. Not in the same league as R-it