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Just to be clear - Are we rootin for the Plaintiffs or Defendants?
HDH - trying to figure out which of your posts this one is tied to
Love the quote!!
LOTR?
Do we even know if there is a call?
JL - I would not be here if it weren't for you. Thank you from the bottom of my heart!!!!!
He truly is the Bhatt-Man!
Good article in the Fool today (sorry if already posted):
https://www.fool.com/investing/2019/11/21/is-amarin-really-a-7-stock.aspx
AF - where did you get the 200M current annual sales? Try more like close to 500M.
In this case, erring on the side of caution would be to grant a very broad label.
Anon - Thx for the post. I disagree with your take on the primary. Toward the end of the AdCom most panelists were leaning to primary. Not that it matters because FDA has the final say. To not grant the primary is akin to homocide by the FDA.
21.26 this morning. Also picked up at 21.35 and 21.38
WTF - "massive volume spikes the last few days but very little price movement to the upside"
Stock was up 24% on 11/12 and another 15% on 11/15. 42% total gain. I'd say that is pretty good upside.
FFS - Understand. The fishing would be the bomb!!
FFS - how high we heading on this run?
IMHO this discussion on Primary is BS. Let the clinicians decide.
So, the person who just spoke is in the camp of wait until you have a heart attack, then you can get treatment.
Any idea why?
Anyone else just lose the webcast?
Serious question - what is it about Amarin that brings out all the nut balls like MRC, Green, others? Is this common with biotechs?
Hey FFS - Where did you get a picture of me?
Regarding any notion of FDA wanting a DDI study, why should AMRN be saddled with that? How many studies have been done/are ongoing that use MO as placebo and have/may have patients on statins?
Anyone familiar with a ScryingBiotech on StockTwits? Perhaps MRC in disguise?
In Bhatt We Trust!
Thanks JL - appreciate as always
Article by the Fool today suggesting that if we only get the label for secondary prevention (hope I'm using the correct terminology, to me this is folks that have already had an event) we'll get quite the beatdown. I'm sure this has been discussed before. But, what do you folks think? Do we gotta have primary prevention on the label?
https://www.fool.com/investing/2019/11/07/reasons-investors-are-nervous-about-amarins-big-da.aspx
Another outstanding letter posted on the AdCom docket today. From Sanjay Srivatsa. Rips MRC.
Rose - Me too. Not sure where folks are getting the 30B buyout
Jeffries from Flyonthewall:
https://thefly.com/landingPageNews.php?id=2987790&headline=AMRN-Amarin-analyst-commentary-
From TerraPharma on Twitter:
🔥Vascepa (icosapent ethyl) added to "Updated Cardiovascular Prevention Guideline of the Brazilian Society of Cardiology - 2019" in 2 sections. Not (yet) available in Brazil. $AMRN #vascepa #icosapentethyl #reduceit https://t.co/JfSaaDmPLr pic.twitter.com/30jcPoJw0U
— TerraPharma (@TerraPharma1) November 5, 2019
Noticed one additional "comment" on the AdCom docket today. From Anonymous. You can't view the attached document as it contains PII. Under "Document Subtype" it says Appearance Request. Wonder who it is?
I think you misread Affords post. BTW, they added 17 of the openings 2 days ago. Rest are 30 or more days old
FWIW, here are some comments made by the "voice-less" Doc that Feuerstein had lined up:
Commenting for TCTMD, Pradeep Natarajan, MD (Massachusetts General Hospital, Boston), called the results exciting because they highlight a new treatment to reduce the residual CV risk seen in patients treated with statins and other types of medications, with a relative risk reduction similar to what has been seen in statin trials.
Asked whether he’d consider using icosapent ethyl in more of his patients based on these results, Natarajan said that it’s important to recognize some potential downsides with the agent, including the observed absolute increase in A-fib-related hospitalizations of about 1%, which is “not necessarily trivial,” as well as cost.
“But aside from that, for patients who have well-controlled LDL cholesterol who are otherwise on guideline-appropriate medicine, this is an excellent option for those with persistent residual hypertriglyceridemia,” Natarajan said. “I’m very encouraged by the results.”
HDG - Thanks, appreciate the response and have great respect for your take on things.
HDG - You still believe we'll have a positive AdCom and get the CVD label? (i.e., still Relax?)
If you have not read the comments on the AdCom docket, do yourself a favor and do so. Very positive, mostly from Docs. Only negative is from, you guessed it, the piss ant MRC.
Only corruption would prevent expanded label
Whal - who was the MD?
Comments continue to pour into the AdCom docket in support of Vascepa. 62 total now. Most are Docs. Only two naysayers; MRC of course and some other anonymous knucklehead (probably MRC).
Does the FDA pay any credence to these? I understand that comments received before 10/30 are given to the EMDAC.