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If you're in the donut hole I suggest looking at your Part D EOB for the month when you made that purchase, usually published around the middle of the following month. You might see that you had premium assistance from your kindly Uncle Sam. I know that my copays on the more expensive items in my med list went down considerably while the insurer paid the same as before. The difference was made up by Uncle (Thank you GWB).
It will be encouraging to hear of reduced costs from people who are not yet on Medicare.
If you have something to contribute it is not apparent to me. Your latest reply is imo a thin-skinned retort to having your bluff called.
Along this line I called Omega Via this morning (sorry but I’m one of those people who doesn’t have a V script and can’t get one) to change my shipping address for current order. While I had the guy on the line I asked him hey what about that lawsuit from some pharmaceutical company. He said oh that’s over it was just some pharmaceutical outfit trying to claim that food was a chemical and they lost. I guess he doesn’t know that the excrement has met the Amarin impeller blade
It's not logic. It's called a straw man fallacy. You constructed a thesis without any proof that "continue" = less than great, then used your flawed thesis in repetitive negative posts.
The short interest you are looking at was as of 7-11-17 (effective date). The closing price that day was 4.05. We can speculate on the short interest now but I think JL's thesis is supported, in that it would not have taken much strategic shorting to trigger retail dumping.
I expect "Big Data" analyses to outweigh trial data in years to come. Trial outcomes may be subject to design constraints and screening criteria biases, but real world evidence is where we are headed imo. Electronic data will show how each risk subgroup responds to each treatment variant, and cost benefit will make clear the winning treatments.
Several months ago I followed a link on some message board to a presentation by a data analytics software company that opened my eyes to what is coming. They had as a model a graphical representation of clinical outcomes to treatment/medication options.
Omegia Via EPA 500 is about $30 including tax for 120 500mg caps, or 2g/day for 30 days, so $60 will buy a 30 day supply of 8 500mg caps/day.
I've heard that grey hair is one of the causes of aging, along with having less-than-new organs.
I agree that more frequent physicals would have exposed the condition sooner. I was in an HMO at the time and the useless PCP had dismissed my complaint of mild abdominal discomfort as my being pre-ulcerous. He prescribed Axid - never ordered any labs. Only after I quit him, chose a new PCP and insisted on a physical did I get one bc at 50 I had outlived my father by a couple of years. I was in peak physical condition for my age at the time, but 5 years after that physical I received a transplant at UCSF.
For all those who discover that running is hard on the body, and progressively so as we race into and past middle age, I recommend, without reservation, cycling. I didn't discover it until I was over 40 and had learned of the stress I had been putting on my joints with the impact of running. Cycling, I mean all-out hard cardio work, was blissful in comparison, and got me into such great shape that I had no clue that my liver was failing, which required a liver transplant 17 years and 1 month ago. The desire to get back on my bike drove my recovery from surgery.
For some people long roads with little traffic (exhaust fumes) are hard to find, but you can get the same workout without joint stress on a stationary recumbent bike.
Repatha ads are out. Saw one about 10:30 am on CNN. very polished - like sugar cereal ads targeting kids. Focused message: lower your LDL.
Thanks. I knew that, but the pre-op nurses apparently don't. I didn't feel like explaining to them that nearly the only time bleeding matters wrt the eye is if the interior is to be penetrated, like for an Avastin injection. I did have one of those several months ago without advance consideration of my drug regimen, and eye was bloodshot for over a week.
I had a cornea transplant two weeks ago and was requested to stop 5 days prior all blood thinning agents such as aspirin, fish oil ....
I should have done the research you did and notified the surgeon that I was not taking DHA.
I did resume my regimen two days after the procedure.
Hey, it really works:
"is PY FOS?"
"Indubitably."
Ran this three times - same answer.
August 2016 was not the 60%th event onset. September 2016 was the "Continue" rec from the DMC. Onset (announcement) of the 60%th event was 3-31-16 and the actual event could have been anytime in Jan or Feb 2016. If 100%th event onset is to be announced on 12-31-17 then the actual event could be sometime in Oct or Nov 2017. Middling Jan-Feb 2016 and Oct-Nov 2017 suggests that the 80%th actual event might have been in Jan 2017 and onset to be announced 3-31-17. We should know soon if this rough prediction pans out.
From what has been disclosed by the co and discussed on this board, onset != occurrence but rather announcement. It is my understanding that announcement can lag occurrence by as much as a couple of months, depending on the frequency of updates received by the co. If they receive only quarterly updates then we could be hearing about a January occurrence at the end of March, and if that's the case the company's previously released estimated timetable remains viable.
I recently managed to use the mfr's coupon for an expensive ophthalmic med by telling the pharmacy to process as individual purchase and not run through insurance (medicare with pdp plan). Paid $60 with coupon instead of $100 more as copay.
Today's hammer on decent+ volume could be a good sign if confirmed.
And I feel good so far about adding today (order placed last night) at 3.22 for average now 3.045
Let's give the guy a break. Most of us are constrained by facts and are compelled to change our positions when we learn something that supersedes our prior knowledge. He is free, unconstrained by facts, because he has his whatever as his guide.
I believe he misspoke. If the trial had been designed for a 5.2p rate, given that the results are blinded and all he can know is the composite rate as adjudicated, then he could not possibly say the trial is tracking close to expectation. HE COULD NOT KNOW the p rate or V rate to-date. He therefore meant the trial was designed for a 5.2 composite rate, as he could then say the composite rate is tracking close to that.
One additional misstatement is also possible. Maybe he meant 5.? and 5.2 came out.
I totally agree that 8 more capsules on top of existing regimen would be a lot to bear. Since my existing regimen is 12 caps/tabs per day (healthy liver txee) and a few months ago added 6 caps/day of OmegaVia EPA 500 (not likely to get a script for V and already spend a ton on meds), I am at my limit. I expect to get most of the 4g/day EPA benefit by taking 3g/day as prophylactic. 73 yo, lipids already ok (not as good as with original liver), no family cvd history ....
If the script is for 1 gram capsules then you are the 4g/day 'cure-all-ills' dosage and congratulations. if you were prescribed the newer 500 mg capsules then you are on the 2g/day better-than-a-poke-in-the-eye dosage. The REDUCE-IT trial is 4g/day vs placebo.
What quantity did you receive and was that supposed to be for one month? Iow, what dosage was on the script? Your question suggests that you don't have a script because the label would be specific re dosage.
A1C from 60 to 55? Do you mean 6.0 to 5.5?
and we all trust the FDA not to reneg on agreements or invent obstacles, right? I have never forgotten the Amarin SPA or the rat cancer torpedo at Arena/s first adcom. I just think Amarin needs a bulletproof set of data.
"Personally I believe Colman was the most likely author of the Amarin SPA or certainly a major player."
Colman launched the torpedo that sank Arena at their first adcom. I don't know who gave the order.
Sorry, BB. I know you've been waging war with the FDA over their actions wrt Amarin, and that your efforts here affect many other shareholders, but I have nothing specific to add. I just can't see any explanation for the FDA's actions against Arena (1st adcom), Mannkind (two crl's), Amarin et al other than influence, both political and, ultimately, financial.
I liken that influence to what the USPTO, PTAB, and CAFC have been doing with property rights related to small business patents.
I wish someone could come up with a money trail, but I believe that the quid is generally indirect and difficult to demonstrate, even though the quo stares us in the face.
There is another reason to tread cautiously when awaiting late stage trial outcomes. One should ask how sound is the trial thesis.
Consider GALE's failed P3 trial several months ago. In the P2 there had been a sub-population of participants, women with low-mid her2 expression, who fared much better than the trial average, so the company designed a P3 for a large set of that population and the 70th recurrence event was to trigger interim analysis. It took long enough for #70 to occur that if the same relative improvement occurred in the treatment arm the drug was a smashing success.
IA showed that treatment was no better than placebo, and in fact the results swung the other way. The trial was halted; Galena was issued a DNR and sent to the morgue waiting room. The thesis was mortally flawed. The company never considered the possibility that the selected population was healthier and less prone to recurrence than genpop. The drug was of no value.
Disclosure: I liquidated my position in Amarin after the FDA indicated that it had been bought, and just recently established a small long position again. I don't expect to ever regain what I lost in AMRN, but am once again optimistic here.
Herpes and the other bio-uneducated writers know less about statistics than they do about biology. The study Herpes referred to was extremely small and there can not be any statistical significance drawn from the single-digit observations re valvulopathy. In fact, if he wanted to think before bashing he might have noticed that the rate of occurrence in the lorcaserin group was close to the same as it was in the very large earlier trials, and that the irregularity in the new trial is the abnormally low rate in the placebo group, which should be similar to the rate in the gen pop. The leap Herpes took to make his conclusion was without any basis in science or in math, or even in common sense. We have to remind ourselves that he is not there to present fact and educated opinion but rather to further the agenda of those who pay him.
AF might be qualified to be towel boy at the YMCA, but he has no scientific or mathematical credentials, none, zip. He doesn't know anything about statistics or he would realize that both numbers reported today, for placebo and lorcaserin, not not stat sig because the sample size is too small. In fact both valvulopathy numbers are below the average expected in the general population and have to be attributed to noise, not data significance.
That won't stop AF and his fellow bashers from making up stories to fill the voids in their crania.
Here is AF's "logic" applied to the hypothesis that all results are to be considered significant regardless of the sample size: "Both placebo and lorcaserin reduced the likelihood of valve disease developing, compared to the general population, although placebo reduced the likelihood more than lorcaserin.
LOL at you. I don't think you have ever said anything positive about Arena, its management team or its drug candidate lorcaserin, and once again you are on the bashwagon spinning the facts. The FDA laid out a fairly mild path to re-submission, tacitly acknowledging the complaint that the rat toxicology was mis-characterized, by offering the company the chance to submit arguments from one or more outside toxicologists on the interpretation of the rat data and inference of risk to humans.
There are CRL's that present impassible mountains and CRL's that present doable climbs. This CRL has terms that are rather easily addressed, and is in my opinion a best-case result following the skewed panel vote. So I maintain that an intelligent reader, not driven by personal bias or agenda, can not simply characterize a CRL as tantamount to a rejection without considering the terms before passing judgment.
Furthermore, much of the bought and paid for media has come out with "rejection" hit pieces following the CRL. Silly me - I expect reporters to report, not invent, the news. Since the expected CRL was announced how many articles have been published discussing the path forward that is a part of the CRL?
A class 1 is expected to have a very fast response time from the FDA. As I understand the process, the company presents the re-submission and then the FDA responds within a couple of weeks with an acceptance letter and a re-submission classification, and if they indicate that it is Class 1 then the PDUFA date should be only a couple of months after the acceptance letter. So if Arena gets their re-submission together within several months and gets a Class 1 acceptance then we could be looking at a new PDUFA date as soon as say 6-8 months from now.
The funny thing is that the piece is a consummate fraud. Neither Jack Lief not anyone else at Arena issued such a PR. The company did issue a PR describing the FDA complete response letter but nowhere in it was the idea that the application had been rejected. The smear campaign by the hedge funds and their paid whore media toys has twisted a positive best case response letter into doom and gloom.
Jack Lief walked out of the AC panel meeting when he realized the deck was hopelessly stacked against the company [my observation], but since the panel meeting several qualified medical researchers have contacted the FDA to indicate that the rat toxicology data that was used to intimidate the unqualified [in rat toxicology] panel into a no vote was mis-characterized and that correct analysis demonstrates no risk to humans from the rat study results. The FDA has in their response letter to Arena agreed to hear arguments to support this position. The FDA stated in a letter that they regretted the fact that there was no qualified animal toxicologist on the panel [especially since animal toxicology was to be the focus of the argument against approval]. This is a hugely positive turn from the attitude at the panel meeting, indicating that the FDA wants to take another look.
On Efficacy, Arena will add to their data the results of the Bloom-DM trial which should be unblinded within some weeks, and these results should support the results already reported, that there was an average weight loss of 8% and broad improvement over many secondary measures of health risk. Comments by qualified diabetes researchers have stated that 5% weight loss will cut in half the number of obese patients who progress to T2 diabetes.
Essentially, Arena has been invited to present the data again with the DM addition and detailed analysis from outside toxicologists of the rat data. This is not a rejection and the company did not characterize it as a rejection in their PR.
OOPS! That's gonna leave a mark.
I think a quick resubmission including not only the DM data but a scientific rebuttal to the bogus rat crap would be just fine. Arena could get a new PDUFA date within say 9 months at the earliest imo. As a remote possibility I could see amending the current application to include the DM data and detailed rat data rebuttal, with a request to extend the current PDUFA date maybe going a little faster.
It wasn't the panel's fault. The vote was scripted by the FDA. There was, not accidentally, no scientist on the panel who could address the rat tumor questions the panel had. The FDA misrepresented the data, stacked the panel and issued the intimidating warning that their names would be on it. They were right to be confused. They had been used.
Why do you think Jack Lief left at lunchtime and didn't return. Could it be that he realized he had been invited to a lynching and not to a hearing?
You really think your feeble bashing can scare anyone with a brain?
1. Arena has insurance that will defend against these misguided claims.
2. There was no failure by Arena management to disclose anything material, but there was a failure by the FDA to present a materially accurate case to the panel and to have a competent set of experts present. Why did the FDA misrepresent the risk to make it appear stat sig and therefor material, and why did the FDA stack the panel for a no vote by intimidation and by deliberately (could not have been accidental given the moa of the FDA's attack) not have a scientist present who could competently speak to the rat study question?
"ARNA could have done better presenting/killing the rat tumor subject."
I don't think they could have done much better. They did respond at the panel meeting but were drowned out by the FDA's "we don't agree." What was missing was not better preparation by ARNA but an honest panel composition. Why was there no scientist on the panel who could have responded with scientific authority to the FDA's "we don't agree" statement and explained the rat study data's true significance. ARNA needed at least one panel member who understood the science, and another who could refute the absurd combining of benign tumors with cancerous to get to a stat sig number.
You may recall that Jack Lief left at lunchtime and did not return. I think that was his statement that he knew he was sitting in a kangaroo court and that nothing would change the scripted result.