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Yes, Scottrade is/was WAY wrong....and the guy that answered at the local office saw the same numbers, then aksed to call be back "after he talked to someone at trading desk" ...he called back and said that the numbers now were corrected to the .300K range, but oddly enough, my account (I refreshed and cleared cache) still shows wildly inncorrect#.
NASDQ v.Scottrade # of shares traded disparity. Does anyone else use Scottrade? At this moment, NASDAQ is showing 159,813 shares traded today, my Scottrade is showing 1,161,245. Fairly large disparity.
From Doc 53-7 (Thank you HDG) , CURTIS J ROSEBRAUGH writes:
"I would like to address the quote from myself to Dr. Jenkins that you reference in your FDRR."
“Understanding how drugs compare to one another is always desirable, but employing this type of logic along with the scientific treachery of cross study comparison is extremely problematic. Taking action on the basis of such a strategy would set a precedent that ‘suspicion’ should translate into immediate regulatory action.”
If Rosebraugh's statement (quoted above), accurately reflects the general mindset of the Division, isn't it a bit odd that the FDA would rely on the HPS2-THRIVE, AIM-HIGH and ACCORD-Lipid studies as tools to harpoon Vascepa at the ADCOM?
Sam, IMO, your point is 100% correct. This situation is a perfect example of the legal concept of "Impeachment By Prior Inconsistent Statement" (Federal Rules of Evidence, Rule,613)and should be swiftly rammed down FDA's throat (or up some other orifice).
The Government's Answer contains an admission: "72. With respect to the first sentence, the Government admits that the ANCHOR study was not designed to measure the impact of Vascepa on cardiovascular risk," that completely impeaches the voting question as presented to the Adcom Panel.
If the Gov't was aware that ANCHOR was not designed to measure the impact of Vascepa on cardiovascular risk, why then, was the question posed to the Adcom crafted with language that placed inquiry as to the efficacy of Vascepa with respect to CHD or CHD risk equivalent.
Listen and watch starting at 1:44:00 for the slight of hand.
Let me translate this one for you in hopes of providing a bit of clarity: "We, the FDA, actually don't understand what the hell you're talking about. Frankly, our job, as we see it, is to ensure that we make decisions that enhance political and financial benefit to our agency (and, of course, ourselves). Scientific facts, discoveries or medical benefits to patients really don't weigh too heavily into the equation."
Good call, Sam !
OCD? Tourettes? or perhaps he was vaccinated with a phonograph needle
It is laughably ironic that the FDA would dare to use such terms as "vague" or "undefined terminology" in any claim for dismissal. Wasn't it the FDA's reliance on "vague and undefined terminology" that got them into this mess in the first place?
Ajax, You do, I assume, understand that the Doc. is simply response from FDA (Government)and NOT a ruling by the court. With that little tidbit out of the way, what would you have expected from the Government....certainly not an admission that they have their legal heads so far up their asses that they can see daylight?
Reading the response begs a couple of questions:
Did the FDA forget that The Second Circuit was venue for Caronia?
Did they ignore the fact that the Judge and the FDA hold vastly different interpretations of Caronia (and that it's the Judge's courtroom, not the FDA's)?
It would be nothing short of folly to assume that Atty. London would do anything other than try to have claim dismissed. But I am afriad that she and the FDA have screwed the pooch. Re-read the response with an open mind, and I think you'll agree that London is grasping at straws...and unfortunately for her, the straws that she's attempting to clutch are so weak and thin that virtually all, if not all, of them will break at the mere touch of her ham-fisted hand.
Hah, thanks BB... I am not an attorney. I simply happen to find law, and specifically Tort Law to be about the most fascinating subject on earth. Any opinion that I give is NOT a legal opinion, and, as noted, should never be construed as such. I add this disclaimer as I don't wish for my screen name to cause someone to be misled into thinking that they have been provided with legal advice.... I'm just an "average Joe" investor that strongly believes in Vascepa's value as an important drug. Further, I believe that due to the fact that the FDA has savagely raped Amarin and Amarin's shareholders, that justice must be served.
I do apologize to all for the massive amounts of typos recently....In addition to working a few too many late nights in a row, I've been attempting to integrate a voice-to-text program with standard "typing" and have been just a bit too hasty in hitting the send button prior to proofing the content. Sorry.
BTW, BB, I truly appreciate your posts as well as the massive effort and time that you've put into fighting for all of us.
I need to read, learn and think a bit more on the issue before I can give you a strong "gut" opinion", however, my initial impression is that Watson's action might possibly be dismissed very simply by virtue of the "timely motion requirement". If Watson was aware of the action in which Amarin sought the Court's intervention to compel FDA was not fully aware of, and very interested in the case),WHY then, did Watson not file am Amicus brief in the matter at the time that the case was being heard? (as other BPs and related parties have done with respect to the First Amendment case between Amarin and FDA that now sits with The Second Circuit Court??
I am just now looking at this material for the first time after a long day, so please be aware that I am simply "shooting from the hip" in terms of offering a "gut reaction". Please note that this is not, nor may it be construed to be, a legal opinion in any sense. It is merely a quick personal observation based on limited understanding and access to all pertinent facts relating to the above.
I'll read further on this tomorrow morning and expand my thoughts in a more detailed way when I can add to my understanding of the facts as well as applicable law.
JL. Perhaps Hanlon's razor: "Never attribute to malice that which is adequately explained by stupidity" is applicable to some degree in this case. Still, it would be difficult to reconcile some of the FDA's actions to simple ignorance or stupidity... IMHO, the fact that they have repeatedly missed deadlines, quashed comments to various CPs, applied different standards of applying their regulations in their dealings with Amarin vs. other companies, etc. smacks of a touch of bad-blood and malice.
Kenyboy; Try to relax and understand the value of the Judge getting his language and findings right. The last thing we want is some hastily rendered decision that, while finding in our favor, is either shoddily crafted or misses a technical detail that leaves the decision unnecessarily vulnerable to being overturned on appeal.
Kenyboy Re your statement: "Judge should have issued PI by now if he followed laws of precedence!" Please cite the case that set the precedent that you're referring to. Thank you.
WRT "The 4 Doctors"; They can prescribe off-label as they see fit...that is not an issue. The issue is that they are being denied the opportunity for Amarin's reps share truthful, non-misleading information with them, information that may very well be beneficial to their patient's health.
Kenyboy- Your statement "FDA is winning this" simply makes no sense... the fact is that as of this moment, we are waiting for the Judge to issue a ruling. Period.
My guess is that based on the fact that FDA's counsel and the Judge seemed to have vastly differing views on interpreting Caronia that Amarin has a high likelihood of prevailing in their request for PI, albeit, perhaps with modified language defining limiting the scope of what sales reps may share with doctors. Truthful and Non-misleading seem to be pretty clear concepts.
Great find, Zum, great share, Williams! Thanks
MRPHY; Was just reading your archived posts over on StockTwits and it seems that in addition to being a very vocal Short, your statements regarding your holdings, PPS etc. have a great many discrepancies. Have you suddenly gone long?
Thanks for sharing, Shawzzzzzz. The article's wording seems a bit biased in favor of the FDA.
Does anyone have a Law360 subscription and can share a basic summary of the article? It appears (thank you, yet again, for the heads up Willaims4076) that a rather slanted take on today's proceedings is being presented. Is Law360's take on the oral argument really that far out of step with the observations of Stumbling Bear and oneragman?
Thank you Stumbling Bear, I look forward to reading your additional recollections. I truly appreciate your efforts!
Hi BB, I didn't (and won't have time today) to fully check out issues pertaining to FDA's apparent monkey-business regarding Warning Letters and amazing disappearing acts. If you have a moment, would you mind spelling it out for the time-impaired, such as I? Thx!
Wow, you've got that right!
Raf & HD; IMO, the issue and argument at this point should be solely focused the First Amendment issues outlined in Amarin's Complaint. Period. Any deviation will simply cost us money and time. The FDA's unfair treatment of Amarin needs to be address and rectified in sequential steps wherein the merits of each new suit would be enhanced by the revelations of FDA's arbitrary, capricious and adversarial treatment of Amarin that were brought to light by Woodcock in her diatribe response.
To quote the old adage: "First things, First". In this case "First things" is the First Amendment suit.
Absolutely agree with you on this, JL. This case will get mired down and mucked up if other issues (NCE, ANCHOR, SPA etc.) are argued with the intent of gaining a ruling on any issues not specifically noted in Amarin's Complaint. BTW; I'm sure the FDA would love nothing more than to see the case's power and focus get diffused by the introduction of all sorts of ancillary issues...remember, they have VERY deep pockets and almost unlimited time. The suit, as presented, is very clear in terms of it's complaint and the relief being sought.
As Sergeant Joe Friday used to say: "The facts, Ma'am, just the facts".
There will be opportunities to argue the other matters once the First Amendment issue has been settled, and, if suit is ruled in our favor (which I'm 99.9999% sure will be the case),the other issues that were introduced by Woodcock in her rambling, almost incoherent response, will certainly be used to further knock the FDA back into their rat-hole.
Abrams is a formidable attorney and I believe that we're in very capable hands.
Jesse: My mention of a Qui tam action with regard to Dr. Gotlieb was not suggesting that his letter contained any specific allegations of wrongdoing per se. IMO, there is no person supporting Amarin's argument that is currently on record with the Court that is in a better position to credibly expose much of FDA's dirty laundry. I'm sure that, if pressed, Gotlieb would be able to spill a good many beans relating to the FDA's "time honored" practice of obfuscating truth and coercing drug sponsors.
His CV show that he's had very significant high-level access to many cogs in the Government's health care gear. It would not surprise me to learn that in addition to enlisting him for the obvious purpose of reinforcing/supplementing Amarin's First Amendment argument, Amarin's counsel saw additional value in enlisting Gotlieb as his mere appearance on the stage provides a rather loud shot across the bow of the FDA's leaky ship.
Raf, Re your question: " Are there a bunch of companies/products who could piggyback? " Answer: Every Pharmaceutical Co. on earth would "piggyback" on a win here.
If there were ever someone who could become a Billionaire in a Qui tam action, Dr. Gotleib is certainly a candidate.
FDA totally harpooned by Dr. Scott Gottlieb.... one of their own.
Woodcock is probably eating Valiums like they're jellybeans tonight.
" the government’s refusal to accept the lessons of Caronia and cases relied on in that ruling leads it to refight old, lost battles"
A very clear headed statement, however I might have added : "and by virtue of the agency's massively flawed interpretation and understanding of law, science, medicine and logic, can never hope to win in the future."
Perfect-Thank for sharing that , sts.
sts, You'll note that the doctors that are also complainants in the suit against FDA are from NY just ever-so-coincidentally happens to fall under the jurisdiction of the Second Circuit Court (NY, CT, & VT) I'm sure that this is just a wild coincidence and that the OIG would NEVER be enlisted by the FDA to help it's sister agency..... ((((cough))) ((((cough)))) Bullshit!
Zman: The obvious answer is that OIG's attempt is to put ALL Dr.s on notice, but more specifically, I'd say that the doctors who are listed as plaintiffs in Amarin's complaint againt the FDA will can probably expect to be harassed in some manner (extra scrutiny of their prescribing habits, condition of their facilities....hell, even the IRS taking an extra hard look at their tax returns etc.) as the Government's "Benevolent Brotherhood of Mutual Ass-Coverers" plies it's trade.
Zman: Doctors are co-plaintiffs in Amarin's suit against FDA. Their names are in the complaint.
BB, I agree your analysis of the OIG report. In reading that report, we come across this little gem:
"The Los Angeles and New York areas are hotspots for Vascepa and Lovaza, which are omega-3 fatty acids that are used to help reduce high triglyceride levels. Over-the-counter supplements of omega-3 are available."
First off, OTCs and DS are different animals in the eyes of the law with regard to labeling and other control issues. The OIG is, of course, well aware of this fact, yet they lump OTC and DSs together as a single entity for the apparent purpose of obscuring the difference in potency, testing, efficacy, safety, manufacturing methods, purity, (need I go on?) between a prescription drug, an OTC preparation and a Dietary Supplement. It seems that this lack of distinction was intentional, and worded in that manner to cause Doctors & Pharmacists to be wary of prescribing or filling Vascepa scripts for fear of prosecution.
For the OIG to be suggesting that fraud is being committed by the act of a doctor prescribing (or a pharmacist filling) a prescription for an FDA approved medicine when a DS or OTC preparation, containing some amount of one or more of the active ingredients, is available is clearly, very distorted thinking.
The inclusion of Vascepa in their report (as well as the timing of it's release) is highly suspect and appears to have a strong retaliatory angle.
Robin, If the FDA has made a statement in public in relation to a legal action and their response has be entered into the Court's records/transcripts, then, it is considered to be public. An exception to this is in some cases is where the court has elected to put it "under seal".
Barring the need to contend with sealed transcripts, (And they're generally only sealed from the public) a skilful attorney should have little difficulty in figuring out how to reintroduce the statement that is deemed to have persuasive, legal value.
Sometimes you might have to attempt to have your adversary "open that door" for you by attempting to get them to mention a factor or event that, you might be barred from introducing on your own, but once they've "popped to cork", it's pretty much "open game".
Inasmuch as the scope of what is going to considered permissible is limited by statute (as well as, to a minor degree, the whims of the Judge,) statements "from the horse's mouth, regardless of when they they were spoken", that are very closely related to a concept or fact that has been noted in the original summons or complaint are probably going to find a way to become admissible in Court.
Freak69: Do you have an objection to posting content which actually contains substance or news pertaining to Amarin? While posting your comment "bye-bye Amarin" clearly shows your desire and wishful thinking as a Short, to see the stock's PPS decline, it really doesn't add anything by way of intelligent discourse. How 'bout posting something containing a mere scintilla of substance.
Robin, HD is, IMO, opinion correct. The most effective and important thing that Amarin can do at this point is to present argument that legitimizes and fortifies the initial, original complaint against the FDA with regard to the First Amendment...period
Understand; That is not to say that Janet (from another planet---thank you Louie), (et al) at the FDA have not introduced myriad irregularities, ambiguities and legally contentious elements (SPA, NCE/NME etc.) in their most recent response ...They most certainly have indeed done so. In fact, much of the time, I think Woodcock only opened her mouth in order to change feet.
What the FDA has done in their rambling verbosity is to have provided Amarin with a treasure trove of official, "on the record" statements in which they contradict themselves, show bias, and basically admit to extortion. But these are different complaints that can be addressed in other suits.
IMO, the best approach here is to methodically and sequentially "fry one fish" at a time here. Starting (as we have) with the First Amendment case, first. If sequenced properly, each new case that may be brought would be bolstered by the previous case's illumination of the long history of arbitrary and capricious behavior by the FDA in it's dealings with Amarin.
Robin with respect to your comment: "Sad to know that a US Federal agency is this corrupt or this dumb!" I believe that you could substitute the word "or" with the word "and"and be closer to the mark.
BB I totally Agree! FDA clearly coerced and extorted Amarin and Amarin's shareholders. This new piece-o-work from Woodcock has moved to now think that your posts and thinking about applying RICCO laws (Racketeer Influenced and Corrupt Organizations) are probably applicable.