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https://www.yahoo.com/news/just-everywhere-already-delays-testing-121556497.html
Tasty, you may be right. I remember reading /seeing something about a 2nd wave of the flu this season.
We should have been better prepared. Testing should have been ramped up much much faster.
Well Said!
For those that are on Vascepa - how are you getting your insurance company to pay for it? I've seen posts where ppl are paying $47/month.
A few years ago my wife took it for joint pain and it worked like a miracle. Then we switched insurance companies and it is no longer covered (Aetna and Cigna). Mid 40's, pretty normal blood work. She can get a script from her PCP, but last I heard, CVS said a month supply is $250 or so.
Thanks in advance.
Raf,
You can apply whatever "logic" you desire.
More power to you.
Raf,
We were all confident going into the Anchor adcom. How'd that turn out? Point is, there are a lot of variables which you can not control, including human error.
If you're that confident then take up his bet. Its an easy $500.
You can be confident in your DD and make an educated guess as to what will happen at interim. At the end of the day, it's still a guess.
All I'm saying is, it'd be stupid to take up his "bet" as is.
Kiwi/Whalatane/Akanz,
Thats a BS bet and you know it. It is much much much harder to predict a material event like stoppage at interim than to just say that it won't. The risk is far greater and there are so many variables at work for the side predicting the occurrence of event. One has to hit all the variables (some of which cannot be controlled - human stupidity is one) while the other just sits back and waits.
There's something called odds in betting.
Why don't you REALLY put your money where your mouth is and go 20-1 odds. $25 / $500.
How about it? IF so, I want in on this bet.
HDG,
That first section looks like it pertains to administrative proceedings. Does not appear applicable.
That 2nd section does touch upon it. BUT -
(B) “party” means (i) an individual whose net worth did not exceed $2,000,000 at the time the civil action was filed, or (ii) any owner of an unincorporated business, or any partnership, corporation, association, unit of local government, or organization, the net worth of which did not exceed $7,000,000 at the time the civil action was filed, and which had not more than 500 employees at the time the civil action was filed; except that an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 (26 U.S.C. 501(c)(3)) exempt from taxation under section 501(a) of such Code, or a cooperative association as defined in section 15(a) of the Agricultural Marketing Act (12 U.S.C. 1141j(a)), may be a party regardless of the net worth of such organization or cooperative association or for purposes of subsection (d)(1)(D), a small entity as defined in section 601 of title 5;
I concur with North and Comm3rd, you're not going to get attorneys fees here. Unless there is some statute or provision in a contract which specifically states that the prevailing party is to be paid costs and attorney's fees, the court has some discretion in certain instances. The article that you cited touched upon some of it. Me personally, the only times I've seen it is when there is bad faith involved. I'm sure there are other exceptions, but they are rare.
In every single complaint that I have ever seen, that prayer for relief section always includes a request for costs and attorneys fees. As North and Comm3rd have stated, this is Standard practice. Doesn't mean the judge will award it. Even if awarded, I believe there are caps/restrictions on it. The statute clearly says "reasonable." Reasonable according to the feds has its own meaning. Last time I checked, there was a cap of $125 or so per hour. I guarantee you Floyd Abrams charges 8 to 10 times that amount.
Also, there will be no monetary award in either this case or the NCE case. For once thing, the NCE case was for a declaratory judgment on the issue of NCE only. Very narrow in focus. In the 1A case, only a PI has been granted. We are a long ways from a final judgment. I haven't read the complaint so I don't even know if any was requested.
IMO, the only way AMRN gets any monetary award is for a suit on the SPA which amounts to a breach of contract. The problem with this is time. Any suit on the SPA will take a lot longer than 3 months. With discovery, motion practice, court ordered conferences, you're at least 2-3 years away. By that time, the results of Reduce It will be known. If the results are good, nobody cares about the SPA. If the results are horrible, well, nobody cares about the SPA.
Sit tight and wait for the interim. As you had predicted, they will be good and I certainly hope you are right. Right now, the future of this company and our wallets hinges on Reduce it.
Keep up the good work.
It doesn't matter what he thinks about the SPA or the FDA's behavior in rescinding it as capricious and callous as it may be.
Amarin filed a Declaratory Judgment action against the FDA for NCE. A Declaratory Judgment is very limited in focus. In such an action, the plaintiff is asking the court to decide the relative positions of the respective parties in a particular issue. In this case,the sole issue to be decided, and the only issue the judge has jurisdiction over is whether Amarin gets NCE. Nothing more, nothing less.
To the extent that something in the SPA process has relevance to the issue at hand (NCE) then yes, the judge can consider it...but only to the extent as it relates to the NCE designation.
The only way that the SPA issue can get before a judge is if Amarin files suit against the FDA for the rescindment of the SPA, probably under a breach of contract action. To date, that has not happened.
http://finance.yahoo.com/news/nw-bio-refutes-further-false-170300961.html
A public beat down of our old nemesis. Good read. LOL.
Thats not true. The MNKD briefing docs were actually pretty neutral or as neutral as they can be. Did the FDA have concerns, absolutely and rightfully so. But there was no smoking gun aka knockout punch. What you saw was pure market manipulation. Piper Jaffray with their BS "analysis" about how it will be an "uphill" battle. Then of course you get the usual ppl spreading the usual FUD.
Uphill battle my arse. Advisory committee voted 13-1 in favor of approval on type 1 and 14-0 in favor of approval on type 2.
The MNKD adcom and the AMRN adcom were like night and day. The MNKD adcom was much more organized, a lot less hostile and much smoother. Funny thing is, I recognized a lot of the same ppl.
Smith was the chair, Brittain was there as the statistician, Cooke was there.
Smith did an excellent job this time around. All I can remember from the AMRN adcom was the hostility, confusion on what the heck they were voting on, and Hiatt running the show.
This time around, there really was no underlying shenanigans from the FDA. My gut feeling was they convened this Adcom to help them CYA on labeling and post marketing studies.
Lastly, MNKD management was PREPARED!. They knew what they were doing, where they were going and had answers for the committee. In hindsight, while the FDA did screw us over with that BS ambush, the fact of the matter is AMRN management just wasn't as prepared as they should be. They were probably over confident. Who can forget the "coronation" cc afterward.
Going forward I hope they, AMRN management, get their act together.
Thats not entirely true. I believe entry level for attorneys is either GS11 or GS12. I've seen some fresh of the bar attorneys in my agency at the GS 12 level. I had a classmate that is a USPTO attorney and if I remember correctly, she started off as a GS 12 12 years ago. They do get promoted much quicker though.
But yes, they are taking this seriously. You are absolutely correct, they probably googled his name and his linkedin profile popped up. My point was that you don't need an attorney to do this.
JL,
LOL, yea that does sound like my agency. Then again, I work for one of the biggest agencies in the country and one which is known for lack of efficiency. I've only been a federale for 5 years though, so I can't comment on other agencies. But yes, the right hand does not know what is going on with the left hand and it is very departmentalized.
The one thing that I have noticed is that when someone in management gets an idea...no matter how stupid the idea is, and someone decides to run with it....well it become a reality. Sounds like that is what happened here. Some idiot came up with this idea and decided to run with it. I'm hoping its due to their own stupidity and not undue outside influences.
The part about running it thru counsel....that is pure speculation on my part. However, in what my group does, when in doubt, go get a counsel opinion and CYA. It is the sheer stupidity of this decision that leads me to believe they are did not seek counsel opinion or they have some of the dumbest attorneys on staff. I just can't see an attorney signing off on this.
I think we are on the same page here. Mainly, that they, the FDA, is taking this matter seriously.
A routine letter from a member of the general public to the FDA commissioner should not/would not get this type of attention. You generally don't use grade 14 attorneys making $125k/year to screen letters from the general public, only ones that warrant that type of attention.
I'm not saying that there's a conspiracy behind counsel delving into JL's Linkedin profile, only that its interesting. Why his? Yes, he wrote a good letter but there are thousands of shareholders that wrote to Hamburg, Sebelius, etc... FDA counsel can't possibly do a mini background check on all of them.
I'm intrigued not so much as to the act in itself, but rather the motive behind it. Friend or foe. Are they trying to cover their collective rear ends due to the amount of pressure being exerted on them by the EPAinitiative or are they investigating the monumental phuck up known as the Amarin adcom/SNDA?
IMHO, I actually think its a very good sign FDA counsel is now involved. I highly doubt they (review division) ran this by counsel before ADCOM or before they rescinded the SPA. No competent lawyer in his/her right mind, for the same reasons articulated by Lotsaluck in a prior post, would have signed off on it.
JL,
It probably most likely is just benign information gathering. However, if I really wanted to verify the authenticity of your credentials, I'd check with the state board that licenses you. I'm not a user of linkedin, but I would gather that one could lie on their profile. Not exactly the most accurate source of info.
The part about stalking was in jest in response to one of Williams' posts.
For me, the most interesting part of all this is that it is obvious that something that you did touched some sort of nerve. I'm sure the head of the FDA gets hundreds upon hundreds of letters from people, but for her to forward it down to an attorney who actually took the time to do a little cursory background check on you. Well..if nothing else, at least we know they are treating this/your letter with a little bit more seriousness than your usual letter to the commissioner.
I work for another branch of the government and we receive a lot of correspondences addressed to our commissioner, but it is not routine to forward every correspondence to an attorney for a curosry background/identity check. This guy Varrone is most likely a GS-14 General Attorney. It is a waste of resources to have a GS-14 attorney merely verify the identify/authenticity of a doctor who wrote a letter to the commissioner. They have lower level staff for that stuff.
Establishing a dialogue with this guy, whether friend or foe, can't hurt. At this point, any sort information can only help.
Best of luck and pls keep us posted.
Email him and find out why he's stalking you.
Michael Nicholas Varrone, Esq.
michael.varrone@fda.hhs.gov
301-796-8721
St Louis University, most likely class of 2001.
Admitted to practice in 2002.
Count me in.
15500
Of all the theories that I've read, this one is the most plausible. This is an unintended consequence of the ACA.
If that's the case, we should try and contact this guy:
http://video.foxnews.com/v/2789473168001/does-better-health-care-coverage-mean-better-care/
Saw him on the news this afternoon. Orthopedic surgeon. Congressman from Georgia. Vice Chairman of the House Budget Committee. Outspoken critic of ACA from the very beginning.
He talks about letting the patient and his/doctor make the choices when it comes to medical care, not Washington.
JL, May I suggest that you write to him and explain our situation with Vascepa, doctor to doctor. Also, if anyone is from his district in Georgia, please reach out to him.
Found this link on ST.
http://seekingalpha.com/instablog/1077258-ralphey/2330912-amrn-does-the-fda-need-to-be-investigated
Interesting read from a PCP.
Long time observer, first time poster.
I concur with Javel001 100%. I am also employed by another agency in the executive branch of the federal government. The support of the professional organizations will help, but nothing moves us more than a "congressional."
Good luck.