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Abrams and 2 other male Cahill attorneys. I believe 6 other attorneys/assistants in gallery with Abrams. 3 female FDA/Justice attorneys and one female FDA representative. My impression was FDA representative was not high ranking. When FDA attorneys turned to her for guidance, she did not delivery/ was apprehensive. People with power know how to use it.
1bill,
Let me try to clarify at the end of my very quick summary that left much out, but needed to be significantly less than 100 pages.
The judge was questioning the FDA about the statements Amarin proposes. Amarin tweaked statements that are in the court record. (in Amarin reply to FDA). Judge was questioning FDA if those statements were acceptable. FDA has problems with the statements, especially about heart health statement. Judge seems to not understand how the FDA has a problem with statements as it pertains to V, since it is ok with FDA if DS makes basically same claim. I believe after some back and forth, FDA asks if they could have opportunity to make adjusts/additional disclosures. Judge is amiable to that. I think he was trying to see if there could be any agreement on statements and what exactly they will say. Not sure how that will work. Is he going to tell FDA they lost and then asks for what they want proposed speech to say. (Not to say judge will agree with FDA proposed changes). FDA did not want/wasn't ready to make adjustments to proposed speech in court, where Amarin was ready to negotiate it right there.
Amarin stated in court today science was still in flux and no determination either way has been proven. Going to be hard for them to say they have prove after that statement today without Reduce-It.
Judge asked if any discovery needed before he makes ruling. Both parties said no.
Sorry BB. No monetary damages discussed. Stuck to 1st amendment and speech issues. No declaration from Judge as to when he would rule, at least not from the bench.
Stumbling Bear, concur on your posting.
Abrams speaks first. Talks about how 80% of prescriptions for kids are off label. Also mentions that in one year 50% of scripts for V are off label and another year 30% are.
Judge questions about claims AMRN wants to make, DS vs V, and why AMRN didn't go talk to FDA first. AMRN quoted from documents or expanded on those points for much of response. Judge asks if science changes for worse, people start dying, how to address that issue. Abrams responds judge can change order.
FDA's turn. First thing they state that drug has NOT been found to be safe. Judge stops right there and starts questioning about safety as he was under impression that both agreed safe. FDA says no, Anchor study only 700 vs 36 million in the Anchor indication.
Judge mentions all the off label scripts being written now. Questions if FDA has received negative feed back. FDA-no.
Judge and FDA go back and forth, but Judge tries to get FDA to admit that safety and efficacy are different issues, but FDA trying to lump them together.
Judge questions them on DS vs V. How is V not safe? Basically paraphrasing, Judge says you approved V, what's your problem?
Judge questions to FDA if V isn't safe, what is?
FDA goes to disruption and it being like pre-1962.
Judge wants them to answer how DS can make heart claim and V cannot. Judge wants FDA to quantify why not safe, which FDA has no good answer. Judge asks if safety profile was determined for DS. FDA said no. Judge questioning a lot about safety. Asks why FDA did not address any safety issue in June 5th letter.
FDA states it is not ok to make heart claim with disclaimer. Judge questions FDA about whether FDA plans on not allowing DS's to make heart claim. FDA says DS are still going to be allowed. Judge pushes as to why it's a true statement on DS, but not V. Judge having trouble with difference.
Judge questions FDA about truthful labeling and FDA says that can be a basis for prosecution. Judge talks to FDA about Caronia, which he re-read at the break and starts questioning FDA about that ruling. Big difference of opinion between FDA and Judge on the meaning of ruling. Judge asks if any other cases post Caronia, FDA says no. Questions FDA why they have not come out with new guidelines since that ruling and asks FDA if any new guidelines this year. FDA-no. Judge asks if there is a difference between a doctor starting a conversation about V vs a drug rep. starting a conversation. FDA states as long as doctor starts conversation, then speech is permitted. FDA states AMRN cannot start speech. Judge states he reads Caronia very differently from FDA. Judge asks, "If all you have is speech, how do you prosecute?" Judge reads last sentence in Caronia and tells FDA don't you have a problem? Judge pushing his view. Asks FDA if they retried Caronia. FDA-no. Judge asks why not?
Judge asks FDA if they will allow AMRN to do as they ask? Questions FDA about how they can prosecute for truthful off label claims.
Judge questions FDA about how can they allow research papers be discussed in scientific setting, but not by AMRN reps. Also asks about how come research papers can be discussed off label but cannot be distributed by reps. FDA-reprints show intent which is not allowed and can be prosecuted.
Judge questions why allow printing of study for off label use. States it's obvious the purpose of putting it on paper is to use it off label. Judge asks FDA if science changes (for worse) , how would that affect his ruling. I believe judge throws out idea about reporting back to him if changes need to be done. FDA says OK. Judge questions FDA about if V is both a drug and DS at the same time, drug for over 500, DS for 200-499 can label be the same. FDA says yes. Judge questions FDA reasoning since both would be identical. Judge talks to FDA about disclosure AMRN wants to make. FDA says misleading, science is biased. FDA asks for opportunity to counter AMRN disclosure with their own modification if judge rules against them. Judge has problem with most contested disclaimers by FDA are allowed on DS's but cannot be on V.
I would be shocked if AMRN doesn't come out with most everything they want. It seems that the most debate and push back by FDa were about heart claims.
Hearing went well. Big focus on judge on why difference between V and DS. Also big difference between judge and FDA on Caronia.Judge basically told FDA we see it totally different. AMRN is definitely getting some kind of injunction. Judge asking FDA and AMRN about acceptable wordings for AMRN statements that can be made. More later. Have to catch a train
I plan on attending. On the way to NY now. Plan on checking out court house tomorrow. Want to checkout the size of the court room and make sure I can get in. Anyone know how long oral arguments are scheduled for? I am assuming 2 hours, but want to be prepared as I am heading home after. Somebody posted no phones. Good to know.
Doesn't Reduce-It have plenty of diabetics in the study population already. I would think if it comes in as a large success that will be enough for the FDA.
I read most, not all of the FDA response so maybe I missed it, but find it interesting that they state they told Amarin they could not use the Jelis study at the adcom because they have problems with the study, but never give any reasons they discount it.
Amarin needs to first and foremost stay focused on first amendment. I also think they need to address the science, bringing all acknowledgements by the FDA that the drug is safe to the judges attention. This will address any concerns to the judge about potential harm to patients.
Then they need to try to get the FDA to address why they would not accept the one study with the same MOA as Vascepa (basically same drug) that showed efficacy while pushing 3 studies that have nothing to do Amarin's drug that were failures. Hopefully they could get a response in oral arguments.
Amarin is bringing a 1st Amendment lawsuit. They are making claims that their 1st Amendments rights were violated. If I am the FDA, I am going to try to make this about my authority to regulate drugs and the indications that go along with it. If I can get the judge to focus on that instead of free speech, I am changing the tone of the lawsuit, putting myself in a position of strength.
Like I said, I hope I am wrong and there are concessions by the FDA. If they decide to fight, they are going to try to change the fight away from 1st Amendment with the letter setting the table to have the conversation be about regulation and not free speech. That is going on the offense. That is what they want the focus to be.
It seems like there are many posters here that think the letter from the FDA to narrow the scope of the issues means they are going to offer a compromise. I hope that is the case, but can't help thinking the FDA's move is to make this about their right to regulate a drugs indication and try to dismiss any notions it's about the 1st Amendment. Go on the offense and try to change the argument.
I don't think any judge would think it's a great idea for a doctor to prescribe off label without any information (clinical data that met SPA trial endpoints) that is available because the FDA says so. Actually, he would probable think that practice could cause irreputable harm.
The "likely to suffer irreputable harm" part could be covered by the co-plaintiffs, who are doctors. Their patients potentially dying from lack of information on best treatment available I think should cover that!
Worse yet, supplements can make these statements to the general public. Amarin is only asking to talk to doctors, not the general public. Doctors are professionals. The FDA wants you to believe that professionals can't read and decide what's best for their patients, but a bureaucracy can. I think Amarin will win based on that point tying into the 1st amendment.
HD,
I believe that if the trial is not stopped at interim there is one thing we do learn and that is it has "some" level of efficacy. If there is no difference of events between the two groups at interim, I would think the trial is stopped as a failure.
Ragman
Isn't there also the possibility that the study can be stopped at any time after Interim results? The DMC finds something in the data or the p-value is not quite where they need it to be so decide they need another quarter or 2 of results.
Biobill, How much for a copy of the transcript in the NCE case and where do I send the money?
Kiwi,
I agree with your post and believe in the hypothesis that V, whether it's lowering trigs or inflammation, will lower CVD. The evidence(not fact yet) points to a successful RI outcome.
My point was all along, before SPA and after it being pulled back, that the science has not changed. Science is based on facts. The fact of lowering Trigs leads to lower CVD has not been proven as of yet, but this was true before the SPA. The FDA agreed to the SPA with this being the case. They pulled it with this still being the case.
Even if the evidence or assumptions were showing that lowering trigs did not lower CVD,(which it looks the opposite to be true), that is not science until hard facts prove it one way or the other.
No new science(fact based prove)equals no reason that would hold up in court to pull SPA. This is allowing for the fact that the FDA changed the goal posts from lipid profiles to outcomes.
After the NCE case, if we are successful, assuming that there is no compromise between the FDA and Amarin, I hope they bring a case against the FDA for rescinding the SPA. I realize that the case would not be decided(no summary judgement/no trial) before Reduce-It, but also of the mind set that the FDA may try to discredit Reduce-It results. We could simple amend the case to include Reduce-It SPA and safe a lot of time. Time is our enemy and the FDA's friend. If the FDA grants expanded indication, we drop the suit.
Definitely not new science.
4000 BC-dawn of civilization-unknown if lowering trigs lowers CVD.
April 2015- unknown if lowering trigs lowers CVD.
Both are statements of fact. People on this board who I have learned much from and respect have implied the science has changed. Please tell me which statement is wrong.
The SPA was entered into with lipid profiles in mind. V was successful in that respect. For reasons nothing to do with science, it was rescinded. If it was rescinded because of the science, we would have received a CRL long ago and the second statement would not be true. It is about JZ, BP, corruption, little green aliens, feelings, assumptions, whatever, but not about science.
Correct, there are new views by the FDA, but no new science or there would be no reason for Reduce-It.
NCE Matters. Obviously the patents are of upmost importance, but a NCE win would be big for AMRN. Six months ago people were trashing JT as a JZ patsy, horrible speaker and in over his head.
JT came up with a reasonable and focused plan to turn around the company and has executed that plan better than any of the CEO's of fortune 500 companies that I have holdings in. A NCE win would be another feather in his cap showing fund managers he has what it takes to bring this stock to the next level. If they believe in him, they will want to invest and push up the price before interim results more than if they thought some fool was running the company who could squander the golden egg.
Ragman
Do we know if the judge is a Republican or Democrat?
First time posting on this board. I followed this stock for over a year before I bought some right before Adcom. Posts by JL and others had me believe in the science. I have read the last 25,000 posts here. Fortunately, I averaged down below $2, so I am in the money. Have not found a need to post before as all points are well covered.
I do want to throw some things out there. Lots of bickering about valuation and how much a percentage of the statin market we will capture. Don't we have patents that would cover combo pill? I am JT. I had a combo pill in development but shelved it for the time being for lack of funds. I have a trial that I believe is a winner and believe will be stopped in less than 18 months with 40 % efficacy. I just got over $65 million from BB and China deal. Right now I go all in getting the pill ready for positive RI. Why would I wait? I can capture the whole market. If my pill is 40% better than yours, I will own the market. Just look at what generic L has done to L in a short few months. Built a better mouse trap.
I am guessing, so someone with knowledge about the subject can set me straight, but I would think you would only need some kind of 12 week study like Anchor to show a safety profile and tolerances to get an approval. I am not going to argue if we should sell the pill or liscense it, that is for another time, but I do own multiple businesses and have a take no prisoners approach. I would think JT and Amarin mgmt are the same. So why won't we own this market? I don't understand how we would only end up with say 20% of the statin market. There have been even lower numbers thrown out there.
Educate me. Do we own/have to own a patent for each statin/V combo? What's it really take to get this approved? Does management have to tell us they are moving forward on this again?
I wouldn't think so.
Thanks in advance,
RAGMAN