Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Summary?
The analysis is so dumb!
Imagine there is an accident and the car crashes into a parked car.
Who is responsible.
The papers view on why it is not the drivers fault
1. The car was parked improperly
2. The phone call was distracting the driver
3. The lane marking were faded
4. The speed post sign was not visible
Damn it- It was the driver who was not doing their job behind wheels. Don't find excuses in other places.
Everyone tries to explain why the drug does not work and find reasons to suggest the reason behind the efficacy are all these ancillary events.
an absolute junk study and waste of gray matter!
It is not an investigation but speculative bantering
When are prepare it - 2 results due?
I did not even know someone was this silly to test for infections as a part end point! It was absolutel y dumb to do this.
So Vascepa Scripts are taking a big hit and now Generic scripts combined exceed the TG market by almost 100% and there is no patent infringement?
Is this how the courts want to think?
Raf- thanks for posting
Which specific one?
How can there be hundred kf million judgment. Punutive damages? Or lost sales damage?
Did this moron come from Taro?
Until original patent or patent infringement issue is resolved, there is no buyout. If someone wants a agreement, it will be ex-US.
It came out a few days ago affirming the lower courts ruling
Yes! I should have clarified that the standards for neutraceuticals are different. They are not allowed to make certain claims on health benefits. If they had the same standards as drugs, there will be ZERO natural supplement s on market.
https://www.fda.gov/media/81606/download
GNC products are not FDA regulated. Wrong comparison.
Are Fda approved generics different from brands? NO.
When they are different, FDA gives them different bioequvalence ratings and are associated with low dose medications.
4g dose for FDA approved generics will not be different than Vascepa
Well it came out and not surprised that the original ruling held up.
This does say something. Courts tend not to change the verdicts. No wonder Amarin pleadings have been on deaf ear.
@marjac did you file the reply?
Is OmegaVia FDA approved? NO!
FDA has oversight but it can not regulate herbaceuticals and nutraceutical. The only thing that they can eforce is requiring these products to NOT claim any therapeutic benefit.
Your comparison is not relevant to generic
When is the Teva / GSK ruling coming out?
The reason is patient variability. Your blood level of a drug is not going to be same as mine.
If I weigh 300 lbs and you weigh 150 lbs, for the same dose our levels are vastly different.
Hence the argument that the generic has less drug than brand does not hold water.
These differences and “hypothetical “ lower purity are not based in science.
If there is evidence that generics are delivering 2 g instead of 4 g and FDA is clueless about it , then the discussion is different. Otherwise, minor differences (within FDA regulation) do not matter, no matter what we say.
The validated mfg processes will ensure that. The pilot studies are carries out precisely for these reasons.
Unless the companies decide to ditch all the cGMP protocols , the drugs will meet the standards.
There better be good reason for generics to not only launch at risk but now also take steps to ditch mfg standards and also be liable for patients lawsuits.
I an curious what reasons would justify for companies to take this route for a $10-15 million market share?
When you have a drug with 4g dose and high bioavailability, any changes to it's properties will be generally considered within limits and unlikely to have any quality concerns.
4 g is a very high dose for any modern pharmaceutical
The argument on the board is that generics are by " default" selling adulterated and misbranded drugs (Fda terminology) .
Compliance is a two way street. If the police is napping, crooks will be at play. With Pharma , the companies have to worry about liabilities around patient harm as well .
This can also beg the question on why would Amarin not cheat like others. No good reason not to cheat if regulatory oversight is not a concern
The cGMP protocols validate the Mfg process. If you understand the word "validation", you will accept the fact that there are appropriate checks and balances .
Similar to the fact that one can shoplift and walk away without being caught, Mfg can bypass regulations . However, the consequences are NOT pleasant for pharma companies. They will not do such things, especially for a new prescription drug.
Can OTC store brands have issues. Yes, but they will be minor as well.
It does not matter what Amarin claims. 10% for shelf life is an acceptable criteria , unless FDA mandates different standards, which it can. In case of EPA , it does not.
They have strict guidelines, which need to be followed
https://www.fda.gov/media/71722/download
I am not disputing what happens to grocery and milk.
We are talking about regulated pharmaceuticals. Your comparison are wrong.
You can not slap a expiration with out cGMP validation.
Shelf-life is based on that principle. When expiration date on drugs is issued, the degradation at end of expiration can not exceed 10%
No company will wait for 10% . The also will want to sell more drug and generally set the date. When the degradation is less than 6-8%. They will prefer the distributor and pharmacies to send the expired drug than issue expensive recalls. The compliance cost are too much if there is a mandated recall. This will not be voluntary because the drug is considered mislabeled if the content is below 90% and still in pharmacy for sale. FDA will send commandos and seize the stocks .
Drugs degrade. Nothing new here. The drug will maintain upto 90% content or more to establish efficacy and the approved shelf life / expiration.
If we are to claim that the 0-10% degradation product of EPA (less than 0.4 g) is responsible for something terrible that Vascepa does not do, it is a impossible sell.
I am OK with your statement if you want to say FDA is not doing their job of regulating the quality of pharmaceuticals.
There are CHAMP regulations that are required to be followed. If a Mfg can flaunt them , they will.
That is why they are called bio SIMILAR and not SAME.
All generics at FACE VALUE are required to show weight, content uniformity. They also need to establish shelf life via stability testing. Inferior EPA is a myth.
I disagree here.
What is the dose of levothyroxine?
200- 500 MICRO GRAM.
Dose of VASCEPA - 4,0000,0000 microgram.
Capt , you see why BE matters for Levo and not Vascepa.
Thank you.
@marjac When will you be posting the Rule 60 brief here on the board?
Thank you for your hard work
Hey swg_tdr,
Saw your message.
I can not send you a private message. The answer to your question is YES.
I am on signal. Send me your signal info in the private message and I will reach out. Or
You can send me your email as well.
Quote
"Two questions:
1. Why are we just learning this now. Not a single expert said this. CDC kept saying until today that if you are fully vaccinated, you can go back to normal.
2. How is this thing supposed to go away if the vaccines don't seem to do anything to stop the spread (heavy viral load in vaccinated)"
Nothing is absolute. Can you get pregnant even of you take all precautions? Abstinence, condoms, birth control?
Yes . But most will benefit.
1.Same here. Most will be protected.
2.Some will get infected but no symptoms
3.Some infected and some symptoms but Iunlikely to die
4. Some infected will have low viral load
5. Some will be with high viral load but may also develop no symptoms.
It is important to remember that the vaccine was developed based on Feb 2020 SEQUENCE. Far to many mutations since then. We are fortunate that the vaccine is still effective
Why do you say that?
Off label use of Vascepa should complement generic use . Also, current use should shed light on how is for TG.w
Did Amarin ever report what was the off label use of Vascepa prior to Reduce-It?
Since it is mostly the same docs, the same ratio would apply to generics
What database can be used to identify what % of generic prescription is used for Cvd. vs TG?
Let's keep this to Amarin but one last one on vaccinez
Quote- "'ll help you to get started. Total deaths from/with COVID in the USA for those under 40 (50% of population) account for less than 10,000 (1.7%) COVID deaths.
Again, 50% of population accounts for 1.7% of all COVID deaths but you want to inject them?"
This is your logic . SEAT BELTS don't save lives. The number of people dying in an accident is ~30,000 / year.
The seat belt did not save them , so why make wearing a seat belt legal requirement?
This is called Surviorship BIAS.
If the protection were not in place ,WE HAVE NO IDEA OF HOW THINGS WOULD HAVE PANNED OUT.
It also helped us learn that younger are less affected compared to older population . But this is all hindsight 20/20
@postes
Now that I can not disagree with. Personally, Reduce-It was a gift and yes he spared no effort to throw the baby out of the water.
Once Du rules and the error was obvious, the stupid technical argument the took defend obviousness when statistics was behind them was a stroke of "stupidity"
An infection can kill you in a few days. You prevent it, you take vaccine a few times max costing almost nothing.
Also, it may protect others.
Heart disease can kill you too but over DECADES. To prevenr it you take Vascepa for decades. Also try taking Vascepa to prevent other from getting CVD.
Math is simple, ain't it?
Point is there were no disclaimer changes before after or around the time Elizabeth left. Any PR or legal department will send the same canned response .
Thank you. We will share the information to the appropriate people, etc.
With regards to JT email, I have no comment except that any executive will discuss such matter with via legal rather than responding directly to sender
Another avenue where they will talk about such things will be cc and shareholders meeting
You are missing the point? Do you know how many people take flu vaccine each year and how many people die?
If a virus has the potential to kill 0.1% of all infected people with out vaccine, do the math.
No vaccine is full proof. It however does two things:
1. Helps reduce the risk of getting the infection
2. If you get one, it helps you fight it better and almost eliminate the risk of getting intubated and be on a ventilator.
What is it that you find as a scam? If you got side effects, it is normal (good or bad). The vaccine is supposed to simulate a real infection to make real antibodies. Nobody vaccinated needed hospitalization or intubation. That tells you all.