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Can anyone point me to estimates of revenue from the EU once approved?
Nervous as shit like everyone over the seemingly endless collapse of the pps. Not trying to spread FUD, but perhaps the court case is not the lock we thought it was? Sure makes me nervous that so much is at stake depending on the decision of one individual (the Judge)
AMRN???
Hell yes!!!
Everyone still upbeat about the litigation outcome?
MNBio - I hope you’re correct. Any guesses on price?
CBB - here is an article on the new CA law
https://www.lexology.com/library/detail.aspx?g=0b266da7-6645-481f-a98e-a826dab8df58
Agree. Well said
HDG - you are the best!!!
Check out HDGabor pinned post on upcoming relevant events
I know this was discussed, but I presume AMRN would not settle now given the new CA law? (Been catching up on things)
Kiwi - actually I did. Not sure if what mailed me was the flu. Then again, maybe the shot was a dud?
JL - I just got over a bad bout with it. Kicked my butt for two weeks. Hang in there!
BB - only one problem. You were far too polite to the crooked son of a bitch.
Go get em!!!
This may have been posted already (sorry if so). Good read on infringement.
https://www.ipwatchdog.com/2018/06/22/denying-inducement-to-infringe-drug-label/id=98605/
HDG - Greatly appreciated!
JL - hopefully you’ll fare better than me. Lately every time I’ve bought it’s gone down. Beware of the daily 10:00 am swoon. GL
Again, we hear much about the obvious argument which seems a win for AMRN. What about infringement? Per Jeffries coverage one would think it’s not even part of the litigation. Surely there was more on that in the first 4 days? Or will that be the issue for the last 5 days?
DTC Advertising - I'm sure I'm way behind most of you as usual. But from very quick and dirty research, I don't see where the FDA has to approve DTC ads before airing per the following from FDA:
https://www.fda.gov/drugs/prescription-drug-advertising/prescription-drug-advertising-questions-and-answers
Surely, I'm missing something (besides a brain).
HDG
“Meanwhile I am ESL Z...”
What is ESL Z?
BB - question on valuations. My understanding is that the total share count is about 413M while the float is about 358.9M. Difference being shared held in reserve (RSUs).
At our closing Friday (19.91) the MC is either $8.2B or $7.1B depending on which share count you use.
1. Which count should be used?
2. Wouldn’t AMRN have a higher multiple than 5 given anticipated growth?
The idiocy out of California never ends
Me too. At 50 bucks my retirement is good to go and I can sail off into the sunset ??
Thx HDG
HDG - you still working on your latest take on the trial (eg, Coming Soon ....)? Thx
JL - I hear you. I'm akin to a second grader here and I get it. Just from a very pragmatic point of view, Gabor seems to keep saying it comes down to "did the label make you do it". How in the hell do you prove that?
Thx LBL! Good to hear a little more about the infringement issue
This infringement issue is gonna be the end of me! Are they gonna infringe? Or course! But, my understanding is it comes down to whether or not "the label made me do it". It just seems unprovable to me. It would seem any Dr knowledgeable in lipid disorders would prescribe longer than 12 weeks regardless of the label specifics.
Very uneasy about this!!!
Perhaps stupid question but, are DRL and Hikma joined at the hips in this trial? I mean, could one settle and the other not?
The JPM presentation posted on Hikma’s web site (investor section) has the $752 number
Thx - did not realize our margin was that much
Yep, one only need look at AMRN revenue to know
Cal - tend to agree for all the reasons you stated! Curious that Hikma throws out a projection that matches AMRN 2020 guidance. And, AMRN’s includes CV indication. How could Hikma throw out the same revenue projection when supposedly only going after TG > 500 market and to boot, wouldn’t they undercut price?
How can we be so sure generics could undercut on price. AMRN (to quote JT) is a volume play. Do generics have some sort of magic process to produce V cheaper than AMRN? (don’t mean to be facetious, but can they really undercut AMRN?)
How can we be 100% sure that #1218 is Hikma presentation?
TTE - Thx. Seemed to me the trial jumped from AMRN witness on infringement to the obvious issue. Personally, I’m more concerned about infringement as I think it’s a “tougher” win
TTE - did defense ever present their witness for the infringement issue?
Anyone know if defense presented their witness(s) on the infringement issue? I thought that was due up yesterday but instead the obvious issue was addressed.
FWIW - Court notes from yesterday (Docket #348):
THE HONORABLE MIRANDA M. DU, U.S. DISTRICT JUDGE
DEPUTY CLERK: PEGGIE VANNOZZI COURT REPORTER: KATHY FRENCH
COUNSEL FOR PLAINTIFFS: Megan Keane, Christopher Sipes, Michael
Kennedy, Jeffrey Ellikan, Alaina Whitt, Han
Park, Daniel Farnolly, Eric Sonnenschein
COUNSEL FOR DEFENDANT HIKMA: Charles Klein, Eimeric Reig-Plessis, W. West
Allen, Clair Fundakowski, Allison Heydorn
COUNSEL FOR DEFENDANT DRL: Constance Huttner, Michael Rounds, James
Barabas
IN COURT PROCEEDINGS: Bench trial, day 2
Proceedings begin at 8:33 AM. Also present for Amarin: Joseph Kennedy as corporate representative, Barbara Kurys as patent counsel and Litigation Support Technician
David Brooks. Also present for Defendants: Neema Kumar as corporate representative for Hikma, Andrew Allen and Deeph Jain as corporate representatives for DR and Litigation Support Technician Stephen Gros.
Ms. Keane advises that there is an error in Defendant’s demonstrative slides used in cross examination of Steve Ketchum. Mr. Sipes suggests that Defense counsel could prepare a chart citing the specific “DDX” numbers. The court will address the concern later in the day. The Court encourages counsel to meet and conferment o reach a resolution.
Matthew Budoff is sworn to testify. Mr. Kennedy examines the witness. Plaintiff’s exhibit 1186 is marked and admitted. Stipulated exhibit 940 is admitted.
Recess: 10:18 AM – 10:39 AM.
Direct examination of Steve Ketchum resumes. Plaintiff’s exhibit 1161 is marked and admitted. The witness is qualified as an expert in the areas of clinical treatment of lipidemia, including TG, and cardiology. Plaintiff’s exhibits 989 and 269 are marked and admitted.
Recess: 9:12 AM – 9:38 AM (to resolve a technical issue.)
Direct examination of Matthew Budoff resumes. Plaintiff’s exhibits 566, 1203, 1209, 288, 289, 277 and 285 are marked and admitted.
Recess: 10:55 AM – 11:21 AM.
Direct examination of Matthew Budoff resumes. Plaintiff’s exhibits 26, 25, 22, 30, and 31 are marked and admitted.
Recess: 12:24 PM – 1:04 PM
Ms. Klein conducts cross examination of Matthew Budoff. Defendant’s exhibits 1982, 1632, and 1578 are marked and admitted. . Defendant’s exhibit 1554 is marked.
Recess: 2:55 PM – 3:16 PM.
Cross examination of Matthew Budoff resumes. Defendant’s exhibits 203 and 2247 are marked and admitted. Mr. Kennedy conducts redirect examination. The witness is excused.
Mr. Sipes advises that Plaintiff closes their case.
Ms. Fundakowski presents Defendants’ Rule 52(c) motion. Mr. Sipes responds. The Court reserves its ruling.
Jonathan Scheinberg is sworn to testify. Mr. Reig examines the witness. Defendants’ exhibit 2226 is marked and admitted. The witness is qualified as an expert in cardiology. Defendant’s exhibits 1953, 1957, 2266,.1984 and 1679 are marked and admitted. Defendant’s exhibit 1960 is marked. The witness steps down.
The Court advises counsel that it will issue an oral ruling on Defendants’ Rule 52(c) motion. For the reasons the Court has placed on the record, Defendants’ Rule 52(c) motion is denied.
The Court has reviewed the 25 exhibits Defendants added to their exhibit list. The court encourages counsel to resolve the evidentiary issues. The Court will not exclude the late disclosed exhibits. Plaintiff’s oral motion to exclude the late disclosed exhibits is denied.
Counsel agree to file the chart referencing the exhibits, page numbers and “DDX” numbers Mr. Klein utilized in cross examination of Steve Ketchum in CM/ECF. The Courtroom Administrator will file the minutes of proceedings for January 13, 2020.
The bench trial is continued to January 15, 2020 at 8:30 AM.
Recess: 5:32 PM.