Yes they publish the results of their meeting tomorrow. See the "highlights" section here:

https://www.ema.europa.eu/en/committees/chmp/chmp-agendas-minutes-highlights

Note the highlights for the Feb 24-27 meeting was published on Feb 28.

The highlights are just basic and not detailed. What we want are the minutes, which unfortunately take about 3 months to post.

Regardless, we won't see anything important in either the highlights or the minutes. Vascepa is clearly on the agenda under the "List of Questions" category which means they have given a list of questions to Amarin. We will never see the list of questions.

Remember what Thero said at the earnings call in February. He said we are waiting for the Day 120 letter from EMA and, if there is nothing surprising in that letter, we will begin to explore opportunities in Europe after that date. That date is today.

Kev, it's a bit more complicated than that. The clock is stopped to give Amarin time to answer the questions. After Amarin submits their answers, the clock re-starts. EMA then has 60 days to make a decision.

Amarin has up to 90 days to answer the questions. So if Amarin answers the questions in 1 day (which won't happen) then it will be at least 61 days before we see another update.

And EMA does not give updates on a rolling basis. They meet once per month. The possible meeting dates for their Day 180 decision for Amarin are June 25, July 23, or September 17. August gets skipped. The soonest we would hear ANYTHING is June 25.

The EMA 120 day decision for Amarin is not delayed. It is on the agenda for the meeting taking place March 23 to March 26.

https://www.ema.europa.eu/en/committees/chmp/chmp-agendas-minutes-highlights#agendas-section


Vascepa is listed on the agenda under "List of Questions". This means that they did not immediately approve Vascepa on March 26th (which was always a very small possibility) but instead they issued a list of questions to Amarin. This causes a "clock stop" and it will be about 2 months before we have another update on the EMA status.

In other words, everything is proceeding as planned with Vascepa in Europe. No delays.

Options are showing a lot of activity. These purchases have been made today:

4,000 call options bought at $14 strike for March 27
4,500 call options bought at $15 strike for April 3
26,000 call options bought at $20 strike for April 17
23,000 call options bought at $13 strike for April 17
3000 call options bought at $15 strike for April 17

These are NOT cheap lottery tickets. In particular those $13 calls for April 17th cost about $3.40 each for a total of 9 million dollars.

Joe, as per MTNB's own investor presentation they still need to complete their phase 2 trial against Vascepa (they've quietly delayed those topline result from Q2 2020 to Q4 2020) and then a phase 3 trial with estimated topline results in Q3 2022. They have not yet delayed that phase 3 timeline but we can safely assume that will be delayed to Q4 2022.

So that's the timetable we're looking at with MTNB. By their own admission they won't even have results to submit to the FDA prior to the end of 2022. Then the FDA will take 9 months to review that. We are talking about competition from MTNB, best case scenario, in the middle of 2023. By that point Vascepa sales will be in the billions. MTNB is just way too late to the party here.

Acasti received a notice of compliance from NASDAQ. They have 180 days to recover over $1.00 for 10 straight days or they will get removed from NASDAQ.

They have nothing notable happening in the next 180 days too. They're hoping for data release and FDA meeting in late 2020. They might not even make it to that point.

Leland Gershell's $7 price target looking great for them right now.

BB, the OPDP reports a 100% success rate with adjudicating these advertisements within 45 days. This is not one of those "the FDA hates Amarin" moments.

Our first major milestone for the EMA approval is March 26, 2020. That is the CHMP meeting where they will have the Day 120 decision for Vascepa. (For those who want to do their own research we are on the "A36" timetable)

At this Day 120 deadline, Europe can either decide to (a) approve Vascepa outright or (b) send a List of Questions to Amarin. From my research, most drugs get the List of Questions and very few get approved this early.

My interpretation from yesterday's conference calls it that Amarin is going to review the List of Questions which they will get on March 26th. If the questions appear to be routine and there are no red flags, I expect them to start negotiating for a Europe partnership after March 26th.

Unfortunately for us, March 26th triggers a new deadline where the ball is in Amarin's court. Amarin has up to 90 days to respond to the List of Questions. I think Amarin will drag this out as long as possible because they want to partner in Europe. In other words, they will delay Europe approval as long as possible unfortunately.

This looks like an intentionally deceptive update from Oppenheimer. He knows that January is the worst month of the year for prescription numbers. So he intentionally compares January 2020 to December 2019 to create a narrative that the script numbers are not going up. He's taking advantage of the one weak month of the year.

Oddly enough he still predicts 650-700m revenue for 2020, which is a 65% increase over 2019. So his update argues for no revenue increase, while simultaneously admitting there will be a 65% revenue increase.

Do we have an estimate of when the EVAPORATE trial will be completed? I've been searching all over and I can't find much. It has been more than a year since they bothered to update the trial on www.clinicaltrials.gov, where it estimated completion in September 2019.

It is not clear when the 9 month interim look was available. Obviously it was available prior to November 2019. If the interim was available in, for example, May 2019, then our 18 month should be finished right about now.

I asked IR yesterday if they have submitted the advertisement to OPDP. Elisabeth responded that she is not at liberty to disclose. However she did refer to "the ad" in a sort of present tense which implies that the commercial is completed. My amateur interpretation is that it has already been submitted to OPDP.

I think you are overthinking the MRC situation. He's just one guy, an individual investor. He's not actually investment tons of money into his stock picks. If he did actually invest money into his stock picks, he would be bankrupt. His broker would shut his account down. Notice he has never even once posted a legitimate screenshot of any of his investments.

It looks like he has been deleting his $TSLA tweets again. He had one yesterday where he said he opened a bigger short position at $724. It's gone now.

He has been steadily posting and then deleting $TSLA short positions since about $245.

It doesn't feel like it due to all the negativity and the stock performance, but according to CaptBeer's graph January 2020 will have 46 million caps and December 2019 had 40 million caps. That's an increase of 15% in a month. I hope this is correct. I would happily take a 15% increase in the first month after FDA approval.

It is patently impossible that Baker Brothers sold all of their AMRN holdings this week. They hold 43 million shares. Only 4 million shares have been traded today. It would be quite obvious if we suddenly saw 43 million shares being dumped. It didn't happen.

No, the Judge cannot force the parties to settle the case. The best that she can do is to "hint" at what her ruling is going to be and suggest that the parties consider a settlement before she issues her ruling.

Whatever the FDA decided in 2019 is not relevant to the obviousness argument. The question is whether a skilled person would have found it to be obvious back in 2008/2009 that Amarin's combination of omega 3 would lead to the CV benefits we are now seeing.

Personally, I don't think it's even a close call. Nobody in the world thought that was "obvious" back in 2008. Nobody in the US even considered it remotely obvious until 9/24/18, and even then doubts remained for another year. And the generics are not allowed to use Amarin's own evidence against Amarin (whether or not Amarin internally believed it was "obvious"). It must be objectively obvious to a hypothetical person.

Generics have a major uphill battle here in trying to prove that this outcome was obvious back in 2008.

Raf, here is a quote taken from an article on obviousness:

"According to the Court, when a patent simply combines previously known elements to produce a result that was no more than expected, the combination would be obvious. On the other hand, inventions involving known elements that work together in an unpredictable manner would not be obvious."

To be thrown out, a patent must be obvious to a skilled person at the time the patent is made. The standard is clear and convincing evidence.

The generics need to prove, by clear and convincing evidence, that the Vascepa patent produced a result that would have been obvious to a skilled person at the time the patent was made (either 2008 or 2009).

I have no idea what you're talking about. Did you just lie and pretend to be a patent attorney at a top New York law firm? Your writing and attempted legal analysis proves otherwise. You seem to fundamentally not understand motions in limine and their purpose.

I stand by my analysis of the Judge's decision from yesterday. I described it as a small victory for the generics, and noted that the issues resolved yesterday are not major components of the case. I gave the generics a 15% chance of winning and I still expect the case to settle.

To be clear, I am not a patent attorney. I do civil litigation, which makes me very familiar with the current evidentiary and discovery disputes in the Amarin trial.

edit: I looked up your info. You went to Fordham Law School, but you don't work at "a top New York law firm" nor did you work as an attorney for Kenyon & Kenyon. Not sure why you are falsifying your credentials like this.

Yes. Any witnesses or documents relating to "obviousness" has to be disclosed to Amarin before trial. There are no surprises in these trials. Both sides know all the witnesses and all of the documents. They've taken the deposition of every witness and already know what every witness is going to say during trial.

The issue from today - Dr. Lavin - is not something new. It's something that has been part of this lawsuit for a while. And whatever Dr. Lavin did or said is apparently concerning to Amarin, because they want to have his evidence and testimony removed from the trial. It is hurtful to Amarin's case so they wanted it removed, and failed.

Hayward:

I expect Amarin to settle before, or during, trial. Remember that Amarin has everything to lose, and the generic companies have nothing to lose. If the generics lose here, they'll just go chase down some other name-brand drug to compete against. They have 1000 products, Amarin has 1. I think Amarin has made some good, but not great, settlement offers and the generic companies are holding out because they know how important it is to Amarin.

To clarify your other question, I didn't say the generics have a 1% chance of winning. I said that today's ruling from the Judge increased their chance of winning by maybe 1% in the grand scheme of things. Overall I would give the generics a 15% chance of winning but please note I'm not a patent lawyer.

I'm a litigation attorney. Here's my analysis:

1st negative: (Defendants' motion granted in part) The Court mostly agrees with Plaintiffs, but also agrees with Defendants that Plaintiffs’ experts will not be allowed to express opinions at trial that were not included in their expert reports. Plaintiffs’ experts are prohibited from testifying about the rat and mice studies at trial to the extent they did not rely on those studies in their expert reports.

This makes zero difference to either side. These are just general principles of litigation. An expert cannot testify about a topic at trial if the expert didn't put it in their written report. The Judge is just reiterating what the rules are.

2nd negative:(Plaintiffs' motion denied): "More substantively, the Court agrees with Defendants that while Defendants bear the burden of establishing obviousness by clear and convincing evidence, and that burden never changes, it is easier to carry if Defendants rely on evidence of obviousness that was not presented to the patent office—such as evidence that Dr. Lavin later backed away from key factual assertions he made in the Lavin Declarations.'

This one has some substance. Amarin moved to exclude testimony regarding Dr. Lavin. I don't have that testimony but it is clear to me that it relates to the patent office: what the patent office wss told when the patent was issued, as compared to what the parties now know, about obviousness. In sum, the generics are allowed to present additional evidence of "obviousness" which gives them a higher chance of winning that argument.

3rd negative (Plaintiffs' motion denied): While the Court does not rule today on the proper priority date for the patents in suit, Defendants may make a priority date argument at trial—because the Court sees no good reason to rule to the contrary.

This is another non-issue. No ruling by the Judge. Just reiterating the rules and delaying the decision until trial.

In my overall opinion, not much was gained or lost in the rulings today. Slight advantage to the generics but these are very small topics in the overall scheme of the trial. I'd be hesitant to even say this gives generics a 1% higher chance of winning. This is not pivotal stuff for either side.

"supplement" is defined in this FDA letter on page 1. It is defined as supplement 35 (sNDA-35) which is the NDA that Amarin submitted this year.

So when Footnote 54 refers to FDA's basis for approving the supplement, they are referring to the 2019 sNDA.

Am I reading too much into this FDA response, or does it really say that FDA approved Vascepa's supplement? It doesn't say FDA supports the supplement. It doesn't say FDA recommended approval. It doesn't defer to the Advisory Committee. It says "FDA's basis of approval for Vascepa's supplement".

Footnote 54: Petitioner criticizes Amarin's analysis on the possible interaction of mineral oil on drug absorption. See Petition at 15-16 and 66-80. We also questioned the methodology of Amarin's analyses, and thus we conducted different analyses to estimate the effect of the increase of LDL-C in placebo on outcomes. Because FDA conducted its own analysis as described here and in the Briefing Document, which formed FDA's basis of approval for Vascepa's supplement, FDA will not address the validity of Amarin's analyses and Petitioner's assertions regarding those analyses.

Did you get a picture afterwards? I was sitting with Thero and got a picture with him after the vote. Felt bad because he was in a major rush to meet with his team.