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Interesting move the last 3 weeks with such low volume.... this will move quickly in either direction with any news...
Should be a crazy ride
Bio - on the surface that makes perfect sense....but there could be conditional deals already in place based on successful milestones ....like:
Sale of company based on label approval of.....
Europe partnership deal based on US FDA approval
Lots of things in play where we have zero insight right now
I think we will all be fine and back in Vegas sometime in first quarter of 2020
ICER REPORT IS NOW OUT
We we’re screwed by Goldman....deep sigh
Goldman starts Amarin at Neutral amid 'bullish' consensus expectations Goldman Sachs analyst Paul Choi initiated coverage of Amarin with a Neutral rating and 12-month price target of $17. The shares closed Monday up 23c to $15.45. The Street's "bullish" forecasts "necessitate near-perfect commercial execution," Choi tells investors in a research note. Pending FDA approval, Amarin is poised to start promoting Vascepa, which is already approved for patients with hypertriglyceridemia, with an expanded label in a much broader population, which could drive "significant" sales growth over the next several years, contends the analyst. However, he believes that consensus expectations have set a high bar for initial uptake relative to prior cardiovascular launches. This could limit share outperformance over the next 12 months, says Choi.
Read more at:
https://thefly.com/landingPageNews.php?id=2975248
Ouch - don’t like that answer.
Wow - well done. Evidence continues to mount against this fraud who has one goal in mind - bearish thesis on AMRN.
He is working hard lately to spam his own twitter fee with other gibberish (non AMRN related) to make it mask his only desire to live is to destroy AMRN. He want people to think he is a true research group - WHAT A FRAUD.
In RAF we TRUST!!!
If anyone has a success story or is a prescribing doctor with success stories - then I request you make a comment at the link provided by rafunrafun in previous post. Our JA non-friend MRC was first to post and make a comment. We need to dilute his noise.
Somebody send some Vascepa to Bernie.
Any retired people here should start sending Bernie’s camp all kinds of Vascepa collateral.
Did you respond with a follow up.....are you planning to use any of that data at the adcom? Was any of that data shared with FDA to be used in PUDFA decision?
Anyone bored enough with life they decided to sit in on the ICER meeting today?
Maybe even our favorite clown MRC makes an appearance?
If that is the main question - does that not make the 3 month delay even more pathetic!!!!!!!
Vascepa & Amarin continues to be underrated!
Auburn Tigers are a legit contender and also underrated!!
MRC is fake news!!
That is all!!
<EOM>
That’s my understanding - this does not help with our adcom or our PUDFA decision. - at this time
“The FDA will continue to ensure that any scientific and regulatory issues raised in a petition are considered prior to the product approval, as citizens petitions can raise relevant concerns.”
This above is a quote from the FDA’s new guidance released on Sept 18: “FDA In Brief: FDA issues final guidance to address ‘gaming’ by the use of citizen petitions”
The guidance does go on to say:
“The guidance describes the FDA’s current thinking on what constitutes a 505(q) petition and some of the factors the agency will consider in determining whether a petition is submitted with the primary purpose of delaying the approval of a drug application. If the agency determines that this is the case, the FDA will consider whether the petition can be denied on that basis and may in any case note this determination in the petition response, which is posted publicly. The agency believes this will provide an additional deterrent to pursuing these tactics. By addressing challenges associated with this type of petition, the FDA aims to improve the efficiency and predictability of the drug review process and to help to drive down the costs of drug development.”
Full guidance can be found here:
https://www.fda.gov/news-events/fda-brief/fda-brief-fda-issues-final-guidance-address-gaming-use-citizen-petitions
MRC has lost his mind on Twitter.
He might actually be the most pathetic hateful person of all time! The hate he has and the desire from him to see Amarin fail is nothing I’ve ever seen.
It’s almost sad to think a person is so full of hate and is so pathetic.
The amount of joy I will receive in Amarin succeeding will trump all the money I might make. He truly is a complete &@&$:$!!!!!
PACER updates anyone?
Based on the committee taking comments from the public - I visualize MRC busy at work finishing up their 450 page comment to include his MO thesis. I can’t wait to see his comments....his last chance to derail it.
The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 13, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
Comments received on or before October 30, 2019 will be provided to the Committee.
MRC WAS EMBARRASSED
look at his ICER questions and their responses
https://icer-review.org/wp-content/uploads/2019/02/ICER_CVD_Draft_Report_Response_to_Comments_09122019.pdf
Form letter
Per request:
The ?? (clown) has 211 followers on twitter
BOOM!!
EOM
Some news is out there we aren’t privy too??
Either- CRL to push PDUFA date out officially must be on way or this action still shows serious worries about the patent/legal matters still in play.
With the rash of positive news, the price action makes no sense.... something is out there...I’m convinced of it
MRC is sending out his research to every federal entity (US and Canada) that he can find a mail address or email for.....could this be influencing anything?
This is just setting up the medical community to turn on FDA in case of shenanigans by FDA.
Getting public and medical community fired up and on your side as the fight goes on.
Every little bit helps.
Pyrrh = MRC = Atom
All = FAKE NEWS
MRC Proxy or alias won’t go away
AtomOaks is probably another puppet or an alias
WOW - no way....just no way they can question MO in the adcom
With them going on record in so many ways!!!!!
Wow again
Science will win in the end....
It might take some time to get through all the noise.....but.....
Science will win in the end
IT ALWAYS DOES
BOOM
But BB - they did say on conference call that they were notified via some “template form” of an adcom (assume via email or fax)? It sounds like it was something more then a possible threat of one? If they sent form to Amarin - that must hold some weight?
Can we FOIA the adcom form that was sent?
It’s like he is talking to people in the inside. Everything he’s been spewing out of his mouth seems to be coming true so far.
At this point - his theories seem as probable as many we all have.
What a complete mess
imho - he has someone feeding him info from the inside
I HOPE YOU’RE RIGHT
Conference call is not wise.....they won’t have any more information then what was in PR!!!
This is like pouring salt in wound!!!
Have a call when you have more info
And WTF is this
“Amarin does not plan to update investors further on ongoing communications with regulatory authorities except with respect to potential updates regarding any change to the expected timing of the AdCom or the PDUFA date”
Time to be even more transparent then ever!!!!!
Supreme Court Petition - thanks for posting link.....argument is well thought out and well written.
I’m with you....hard to know how to react here.....do they know trouble is ahead based on some FDA communication so they are beginning the process to gather info to rebuke the FUD?
or is it just to try and show that a true coordinated attempt was made to harm Amarin??
I know I’m confused now
Bakers sold some recently
Geeeze - a methodical and orderly exit to the door....unreal