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BB-
Meanwhile, as I wrote ..., I think the ITC has jurisdiction and I do not think that Amarin will fail in case of an investigation, but I do not have any idea what you mean by "FDA can’t afford an ITC failure". None of the outcome of the ITC case (no inc., inv. but no "ban" inv. and "ban") will affect the FDA.
G—?I don’t think ITC action will fail, the FDA can’t afford an ITC failure. If we are wrong we disagree what would happen.
BB
BB-
It looks like you accepted finally, if ITC case will fail (I do not think), Amarin could not force / sue the FDA to act against the "DS".
r-
Not true. I remember fda saying they no issue with mineral oil
Hondo
Both July & August 2017 were > 100K
July-2017: 100,670 (Retail) // 107,826 (Retail + Institutional)
August-2017: 107,200 (Retail) // 115,227 (Retail + Institutional)
Thanks Sam. October setting up to be the first 100K script month.
1wfal...
Quote: "I think it likely it has some interesting benefit somewhere, but probably not enough on the primary endpoint (or has enough side effects to cause it not to be worthwhile.)."
You still don't get it...Its not the RRR and the P value of the PE...Its about the number of events in the data points..We already know the RRR is going to be fine...Worse case it's over 20%...
You remind me of a saying from one of my old bosses Aurthur Kantrowitz the head of AVCO Everette Research labs..."The rest is just engineering."...Ie. trivial.
":>) JL
BB,
Further evidence that our gov't is inefficient at running programs and should not be involved in healthcare. Bureaucrats don't care about spending, waste, or efficiency just finding a place to stack their abundant action memorandums that re eive no action. I've seen this first hand as a gov't contractor piles of disorganized memorandums stacked ramdomly so when you walked in someone's office you knew they were not doing much because there was no accountability. If I saw it you know their boss saw the same thing. It's all a big money game to give people jobs they don't do. What a waste, sad really.
Here's a thought: Margaret Hamburg (http://ahrp.org/former-fda-commissioner-charged-in-federal-racketeering-lawsuit/) was the corrupt head of the FDA. Big biz wanted to buy AMRN. AMRN wouldn't allow themselves to be sold cheap. You will notice in the lawsuit above that her hedge fund husband's income increased 10 fold during the time we got screwed.
They (we) were spanked for our refusal to knuckle under and go quietly (cheaply).
Yeah...it's all water under the bridge but that doesn't make it right.
Rose-The mineral oil was raised as a false flag and excuse to rescind ANCHOR without any considerations to R-I and the damages the slanderous allegation would have on the future stock action of AMRN. As you can see, the damages are real the stock doesn't trade normally: the value of R-I is not priced into the stock because the FDA has already cried foul with R-I placebo. There's no undoing this except R-I approval and label.
BB
An accurate assessment of what happened. The story unfortunately continued with NCE, SPA appeal, and First Amendment; all intertwined and settled with other forms of extortion. To forgive and forget is not in the best interest of Amarin stakeholders; to excuse what and how the FDA performed is unwise.
BB
Now we are shooting for %40 percent market share. Thanks for the info!
StrangleHold
Of the couple of issues raised in the Adcom, the question concerning the inertness of the mineral oil placebo comes to mind. If that was a concern why is Amarin continuing with mineral oil as the placebo in Reduce-It --if they are???
I apologize in advance if it is incorrect that they are using such in the current trial. If they are, have they not stopped using it since Reduce-It had was already well in progress by the time of the Adcom and really could not change it at that point?
C......."AMARIN was, an is a small company required to run a 7000 modified to an 8000 CVOT study costing approx. $250/300 million.
This study called REDUCE-IT would take approx. 4 years to complete and that cost would be mitigated by sales from ANCHOR approval. The FDA knew that they would be harming AMARIN by rescinding the SPA, "THEY DIDN'T CARE".
IMO the FDA was guilty of extortion......They used the Anchor SPA as bait to extort from Amarin a R-IT study BEFORE(i.e. in return for) their considering Anchor). Then ,once the R-T study was established, the FDA pulled the rug out from Amarin at the Adcom, rescinded the Anchor SPA, and left Amarin for dead, hopefully to bury the evidence of their misdeeds.
Good points about the fact that just looking at biomarkers only doesn't address what may be an underlying reason for that value.
As far as trigs go, with some exceptions in certain people, I find that trig levels can be more easily moved than many other biomarkers. Cutting out simple carbs, alcohol, and exercise can drop the trig numbers quite quickly. At least that has been my experience.
Scripts Update for Week Ending 29/09
ATH in TRx & NRx Market Share
V
TRx: 24,339 {vs 24,604; -1.08%} Sector -1.44% -- {2nd ATH}
NRx: 9,394 {vs 9,431; -0.39%} Sector -1.65% -- {4th ATH}
Ref: 14,945 {vs 15,173; -1.50%} Sector -1.31% -- {2nd ATH}
GenL
TRx: 50,143 {vs 50,900; -1.49%}
NRx: 18,621 {vs 19,051; -2.26%}
L
TRx: 4,032 {vs 4,159; -3.05%}
NRx: 1,694 {vs 1,726; -1.85%}
V TRx Market Share: 31.00% vs 30.89% -- ATH
V NRx Market Share: 31.62% vs 31.22% -- ATH
V Ref Market Share: 30.62% vs 30.68% -- {2nd ATH}
Judge....
The way it works is both EPA and AA compete for the same cell membrane receptors...The EPA/AA ratio determines the fraction of receptors that are occupied with EPA and the fraction occupied with AA. Actually both EPA and AA are pro inflammatory but AA is much more pro inflammatory than EPA is. Therefore when the EPA/AA ratio is high more of the receptors are occupied by EPA and this reduces the inflammation...
":>) JL
JL, If you cannot tell a lie, then my body must be riddled with inflammation: I will know more next week when Quest tells me whether my EPA/AA ratio differs much from last April value of 1.67.
Jo mama- ITC will not outright deny an Amarin victory...it will be a “slow walk” to inaction. Amarin would then report the violations to FDA, likely not public. After an FDA noncompliance and failure to enforce Amarin will have an actionable argument... The FDA is aware of R-I and the FDA’s abilities to win any argument decreases as we approach the final R-I results. It’s not a matter of if the FDA loses, but how much they lose. I haven’t emailed Woodcock lately, but I certainly plan to in the coming months...if she wants her career to end with R-I that’s fine by me.
BB
An accurate assessment IMO.
BB
G—
c-
BB-
I could not find any reference in your post ... e.g. FDA violated the x section y paragraph of APA by z.
So what is the basis of your claim / statement, top of your feeling?
north...
I can not tell a lie...
":>) JL
HDG & JL
Please understand their are many ways to view situations. I for one agree with Bio that the FDA did point blank screw us back on Oct 13th.
Both of you look at it from a medical viewpoint which you are 100% correct. The FDA realized their mistake and found ways to circumvent the situation not to give AMARIN 35 million potential subscribers without positive results concerning trig lowering to lowering cvd events.
I look at it from a business viewpoint as does BIO that the FDA set up and agreed to an SPA with AMARIN. AMARIN was, an is a small company required to run a 7000 modified to an 8000 CVOT study costing approx. $250/300 million.
This study called REDUCE-IT would take approx. 4 years to complete and that cost would be mitigated by sales from ANCHOR approval. The FDA knew that they would be harming AMARIN by rescinding the SPA, "THEY DIDN'T CARE".
They could have modified the SPA 6 months prior to the ADCOM as Bio has stated. Hdg you said maybe AMARIN was informed and proceeded anyway, which could be true. I think the FDA hedged their situation through out the process knowing the power they haD (my opinion).
Now we are 4 years into the study near the end with double the number of shares from approx 170 to 340 million potentially issued. Those shares paid for REDUCE-IT hurting all original investors.
YES, this is now water under the bridge with results forthcoming. YES, we need to put this behind us and look to the bright future ahead. But as investors, we were hurt badly with many of us still under water so to say. PLEASE don't give the FDA any positive credence for what they did.
Why would FDA go after respondents if amrn loses ITC? I appreciate your opinion but law is not my strong suit.
We are hoping amrn wins but in the event they don’t.
Thx.
G- The "law" is the APA, the "regulation" is the draft guidance related to SPA's and SPA communication, the evidence is the Ad Com video or transcript, you chose. For a bonus I can throw in law that regulates Ad Coms and case law that describes "arbitrary and capricious"....for example Judge Moss ruled the FDA would be arbitrary and capricious if the FDA would not rule on NCE. Instead the FDA was vindictive and delay NCE until last possible moment.
PS: I am the definition of vindictive, you can also find LB as a close second place followed by the third place going to Epi.
PSS: If you can't respond in an intelligent manner I suggest you try and insult me...again. You'll find my mental stability fairs quite well under significant pressure...this is my professional opinion.
PSSS: If Amarin loses ITC case and FDA doesn't take action against respondents, Amarin's attorney's will show you further law regarding APA, regulation, draft guidances, guidance, and ANCHOR damages, I promise. The last email I received from JT was clear Amarin stakeholders where going to be priority...then came ITC action.
BB
Zip- You should open an online 50 State DES clinic. ;). BB
"..EPA actually promotes inflammation".... It does????
HDG Ha ...yes since my options expire in late OCT ....you would be fine with a delay in their decision till early Nov ....thx ..
But I have it in black and white from the US International Trade Com
The new deadline is set for Oct 20th 2017 ...dated Sept 25th 2017 ...should be long enough to decide at least on Jurisdiction , me thinks
Kiwi
K-
I am fine with the delay at least till early November ...
Best,
G
HDG ... Well all is forgiven, as long as you are right and the ITC proceeds with AMRN's claim by Oct 20th ....after all I own the call options ..
Kiwi
BB........"Have you been prescribing V off label for DES?'
No......I've been retired for over 4 years.
tasty....
Very well stated...excellent post...
:">) JL
@twi....
Quote: "so ... potentially, reduce-it is many trials in one."
No...R-I is many trials in one...
":>) JL
Have you been prescribing V off label for DES?
Thnks
BB
Supplement maker wins court case against FTC over advertising claims
http://www.newhope.com/news/judge-dismisses-ftc-lawsuit-quincy-bioscience-s-memory-supplement-prevagen?NL=NP-03&Issue=NP-03_20171005_NP-03_686&sfvc4enews=42&cl=article_2&utm_rid=CNHNM000002264067&utm_campaign=23254&utm_medium=email
You have probably seen their commercials on TV
O........When the rep from Allergan used to come to my office to promote Restasis,(a dilute solution of cyclosporin,(which is an antimetabolite/antiinflammatory drug )his message was that it it had to be used for 3 months for the patient to see a significant effect. When the rep returned and was informed by me that I and the patient were disappointed, he replied that the patient needs to continue for another 3-6 months and will have a good result....... Although DES is a widespread, bothersome problem, I eventually discontinued using this ineffective drug.......I guess that from Allergan's point of view they made enough revenue from the patient with this expensive drug, to register a success with the balance sheet, even though it was a failure with the patient.
K-
C'mon man ... Please quote me: when I argued with anybody regarding 1st and 2nd IA (stop or continue). I submit my guess / made my bet ... that's all.
... and yes, I was wrong just like on last week lottery ...
Best,
G
UFO
How much was your copay?
For that perspective, please show where he said that it will be stopped with a 100% certainty? To my best recollection, the biggest PROBABILITY that he gave for the early stoppage was 75% (meaning that he gave a 25% chance that it would not stop early).
In addition, predicting / guessing an event is not the same as winning a factual argument.
DES treatment. $1.4B revenue for Allergan last year.
http://www.marketwatch.com/story/this-billion-dollar-dry-eye-drug-is-behind-allergans-controversial-patent-deal-2017-10-05
Hopefully Amarin is planning a DES trial at some point.
Yes ...lets ignore the arguments over whether or not R-IT would be halted at either Interim1 or Interim 2 .
Just for a little perspective
Kiwi
The good part is: The DMC did not recommend adding another two or four thousand people to the trial. As they have done with other CVOT's. So this tells me the Primary and Secondary event spread is probably statistically sufficient.
Or.... since he is hopping back in for a LONG position, why not spread FUD in the meantime to try to influence some uniformed suckers to sell and to deflate the PPS, so that he could get in cheaper.
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