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HG; I am not sure how this relates to my post unless you are indicating that in Amrn's last appeal that even though up line powers were present and in agreement it still only counts as an appeal to JJ's OND level.
Thanks for all your efforts.
Ms.louie; My thinking is that when presented with the fact that at the last level this battle was waged on, the up line powers were present, and in council with the verdict. The Judge would agree that at that point their was no further need to continue the challenge to higher levels.
Sorry to hear this, Best wishes to your father-in-law and family.
Zum;
If I am understanding your statement correctly, we still will be dependent upon the FDA for approval of a new sNDA. With respect to being able to provide truthful off label infomation we will be able to do that immediately if we are awarded the temporary injunction that Amarin seeks which would come before adjudication of the 1st amendment suit.
Thanks for your outstanding DD it has without doubt been the cornerstone of my confidence in this investment.
Maybe we could get bidmark's teacher to draw a circle on the floor where NickHous's teacher could make Woodcocky (didn't like her comment about repackaging Amarin as a DS) read it to the Adcomm's members who voted against approval, all in the spirit of furthering their education. Of course JL would probably have to supply Cliff Notes.
Nice friend!
Raf, please provide link or source. Thanks!
Best wishes sts66; I think the FDA is and will become less of a negative factor as time moves on. They were and to some extent are an obstacle whose hump we are on the downhill side of. Increasing scripts and market share, The 1st amendment case, showing the willingness to challenge the FDA and go after patent infringers and all the attention these things bring help secure a path that culminates with Reduce-it which in my mind will be successful regardless of the time it takes. IMHO you don't get any clearer look into the future and outcome than was provided by JELIS. This may be naive or even foolish in some opinions but for my money......
Stock_risk; I've been a Amrn stockholder since mid 2010 and have averaged down on dips. Before the marine and anchor results I was here. I sold some in the $16 range but have done nothing but avg down my costs from $14 to about $4.14 presently. I am a long time investor and a true believer in the science. My heirs have been given instruction to hold in the case of my premature demise. Again, I am a believer willing to hold till the end or such time that I determine I've been rewarded sufficiently.
Best wishes.
Rafunrafun; I had an order with my broker that would have put me over 60k shs at an avg of $4.12 approx. just before news of NCE broke and share price jumped. There is no ambivalence in my quest to ride this rag to riches story out. This is not blind faith or exuberant greed it is a well reasoned risk that I see coming to fruition in the not to distant future. That being said I realize the real risks involved here but knowing what I've come to know through people here including yourself and the DD I've done, it's a risk I would take again, no confusion. Sometimes with all considered you have to choose. Best wishes to the lot of us.
OK, what have you guys done with BB.......noticed this "Administrative Warning" box. Now let me venture a guess BB was in violation of "Board Police" and got handcuffed and lead away. Hopefully for not too long!
I would be willing also to share costs providing it was made public to this board,which,I've gotten much from, Thanks to all who've contributed their time and efforts.
Glad to know Bio Chica's better. Being a father, I understand well. Hope you're feeling better soon also, take care my friend!
Kiwi;
quote:
((1) if denied Anchor or expanded label by FDA ...)
This may appear to be irrational exuberance, but with the recent outpouring of info contradicting the FDA's former(I don't mean earlier) position I believe that Anchor cannot be denied only and maybe delayed but inevitably approved even if no longer owned by Amarin.
Just affirming the positive and inevitable as I see it.
Broke 9000, From ST via YMB AMRN 8/29/14 - 9333 TRx 4161 NRx
Regards Kiwi;
Wouldn't you think that Reduce-its positive trial against a background or buttressed against JELIS would be as impressive as the larger trials of that you speak.
Thanks for your contributions.
Williams; It's done.
BioBil;
The excitement of things going our way may be a little to much for some to handle after being in the doldrums longer than any of us wished or imagined. But we all are here because we wished,thought,hoped,or dreamed, sometimes to ourselves or at times to each other on this board or others, that this investment was a little more certain because of the proof of JELIS. Some of us are a little more passionate about things than others and thats one of the things that make us unique. You, like others in your vein have brought much to this board don't stop. I and everyone else here hopefully are of freewill to make our own choices. This board is here to share what information we wish and communicate that which we think is relevant to those we want to share it with. This is a selfless act. I try to take it all in and form an opinion based on the information holding some more valid than other but at least having it before me allows me to see other opinions.
Thanks for all you bring, do your thing Brother.
Thanks BioDad, good looking out. I knew that just got caught up in the message! Hope alls well with the family!
HDG; If as you contend, and I don't disagree, that the FDA has the right to devise new methods for determining active moieties or active ingredients (they should as newer drugs and combinations of drugs are developed). Do you also suggest that they have the right to step back and apply this new methodology to drugs that were ruled on previously to the detriment of Amarin in this case to deny NCE. If that is your position then we fundamentally disagree. Was it not the FDA that suggested that going back to correct past misgivings would be labor intensive and a waste of resources or something to that effect. I do however, agree with you that if this proceeds to court that Amarin will emerge victorious.
It is my understanding that the new policy is inapplicable here as it is new. Furthermore Lovaza's active ingredient was an indistinguishable mixture and Amarin's contention is that since the NCE granted at that time was for the mixture and no single ingredient that the FDA cannot come back now and parse out an ingredient of that mixture and say it was already approved.
I to am a big fan of Williams or BioBil and the incredible DD he does. While some of his ideas may seem farfetched I personally would not have believed that this governments agency the FDA could have ever acted as it has in the ongoing Amarin debacle. So say what you will but I for one take in all said and filter out that which I don't need no matter how ridiculous it may appear on the surface.
Congratulations Bio-Dad, Best wishes for your growing family and may Amarin bestow upon you and yours all you wish.
"The company according to the SPA agreement will not be allowed try the SPA issue in FED Court prior to exhausting the FDA appeals process."
It's seems to me we are no longer bound to this since the FDA rescinded the SPA. Correct me if I am wrong. I am not suggesting any other course of action, just pointing out this apparent flaw. Still waiting with other quiet "legacy longs" (4yrs.)
GLTAL
I don't usually speak for others but BioBill is probably busy doing his thing helping us all. He is Williams from YMB. I cannot speak to his sources just happy to have him with us!
Investor; I think BioBill was giving a range of shares purchased to an aggregate of 100,000 shares.
Thanks Zoo, and everyone who has put forth effort large and small in righting this wrong. Excellent letter, along with your insights maybe mention of Jelis as being the only trial with any relevance as far as comparisons and similarities are concerned and the fact that this trial was not even considered might be a worthy mention.
Happy New Year
Best wishes, labner, And to all those who have taken this to the next level. I though silent, stand with you and refuse to surrender to this gross injustice perpetrated by the FDA (f**king dumb a**holes) I could go on and on about how well written I think your letter is but I will sum it up in two words EXCELLENT,EXCELLENT!
Thanks speedrunner for the effort, count my remaining 25,000 shares and I can also speak to approx 50,000 more between friends and family whom I had influenced.
What a compelling and well reasoned post. You've certainly captured my attention, can't wait for the next must read chapter. Excellent sleuthing gumshoe! As always thanks for your time and diligence. It's our time, GLTAL's
[bO.B. updated through June 01, 2013 is their more to come?
Hi Kaylawa, I think I can speak for most longs here that we miss you. Hope all is well and you and your Aunt can wrap up your business very soon and get back to living and in your case back to doing the things you do so well to further this board. I have been thinking about you as did Palm I just didn't reach out like Palm did, shame on me. Just didn't want to let this opportunity go by without saying it, we've missed you!
Ajax133; Thanks for all you bring to the board. I have an opinion differing from yours on a couple of points.
First: while its true with regards to NCE being awarded at the time of drug approval the FDA puts out talking points for the ADCOM which include NCE, and the ADCOM addresses these points and later before adjourning the meeting votes to recommend approval or disapproval. Their position with regards to NCE could not or should not hinge on the forthcoming Anchor indication but solely on what is before that ADCOM at that time with respect to safety, efficacy, and the best interests of the medical community and people on a whole.
Secondly: "Prior Art" speaks more to the point of not awarding NCE based on the fact that their has been drug approval prior to of one or more chemicals of the drug in question, simply put. For AMR101 this prior art was not so clear cut due to the fact that the FDA did not clearly identify the active moeity in Lovaza, this fact and cleaning up the mess has been the delay IMHO. Best Wishes.
BioChica; The thorn I think is in our side. I am sure after reconsideration you would agree. Best wishes.
BaaBaa; It appears that you have misunderstood or misinterpreted things here. The ADvisory COMmittee is convened to assist the FDA in an area that they may or may not have particular expertise and the Adcom advises them in this area for approval or disapproval of a drug. The FDA does not have to accept this recommendation, also at this convened adcom meeting NCE is or is not discussed with reasons given if it is not. To the point of all this though is that NCE is not awarded prior to the Adcom meeting. Best wishes to us longs.
OK Yellow, Where are you hiding my crystal ball. This is a very real possibility and I like it, I like it a lot!
I think that with the continuing sales growth, combo drug, NCE, patents to 2030 and beyond, Anchor market, and worldwide rights, a fifty dollar plus offer is certainly in the realm of reasonableness for a buyout. Additionally, this could happen well within two or three years......just saying!
How funny, she's a doll. All this time my image was a lady probably a nurse or a very knowledgeable person with a medical background and into bio-stocks and an AMRN long. My image has change but none diminished, in fact greater by the fact of putting your daughter first. As the the father of two adult daughters I appreciate the reverence and love. Happy Fathers day.
Happy Mothers Day Bio Chica, Thanks for all you bring to this board and your efforts the past few year.
Picasel