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North, I will try. The sites that I use to monitor shipping are somewhat limited.
Sleven,
North,
https://pharma.basf.com/product-families/apis
This is a list of API sold by BASF.
Maxomega EPA 96 EE is the relevant API.
Sleven,
North,
https://www.seair.co.in/us-import/product-icosapent-ethyl.aspx
This is the site I use to track API imports. I don't see any shipments from BASF in the past year. I don't know if Amarin is doing any encapsulation in Europe.
Sleven,
Kiwi, Again thanks.
Sleven,
Kiwi, Thanks. I vaguely remember BASF making some acquisitions in the o3 space. I'll look into that tomorrow.
Sleven,
Hikma filled a petition for En Banc review on August 26th. Does anyone know how long it takes for the court to respond?
Thanks.
Sleven,
Study, "Soon" is a fairly vague word. You can't really mark that on your calendar. It is a word that would indicate that reimbursement was not a question of serious concern. At least not for this group of people. I don't know if Amarin has any type of manufacturing presence in France. I'll look tomorrow. I am unable to find any documents on the reimbursement process in China. By that I mean nothing Vascepa specific. Vazkepa is being recommended by clinical scientists who weigh in on what should be the standard of care for both the EU and specific countries within. Eventually this should force the bean counters to give.
Sleven,
Captain, Love your graphics.
Sleven,
North, It is part of the article recommending the use of icosapent ethyl for PAD.
Sleven,
Nuke, I think your missing the importance of the recommendation. The article stated that icosapent ethyl "should" receive reimbursement soon. These are people who have better insight into the reimbursement process in France. Better insight than any of us. More importantly it's a recommendation for clinical use. When physicians are recommending that a product be used, it puts pressure on the reimbursement committee.
Sleven,
JRoon, The remark was not meant to be "snarky". Earlier today you made comments about insurance formularies without understanding that they are controlled by the pharmacy benefit managers. Now you are addressing preliminary injunctive relief without understanding the requirements for a grant. I don't know if Amarin would make That request. It's a few jumps forward. En Banc request. Return to district court. ECT.... Rulings at this point have opened the other generic companies to litigation that can go beyond the pleading stage. If Amarin would request and receive injunctive relief, it would have a profound effect on the other generic companies. Check the requirements for injunctive relief.
I actually have explained this before.
Sleven,
JRoon, Your thought process is impressively linear.
Sleven,
Kiwi, Thanks. I have read that information before. It's useful but vague.
Sleven,
JRoon, I don't know enough about that to have an opinion. I'm not sure what's on the table during a PBM negotiation.
Sleven,
JRoon, The pharmacy benefit managers control the formularies. They are the ones who decide what drugs will and won't be covered by the majority of insurance plans. PBM agreements are at the center of the fight for the US market.
Sleven,
JRoon, I agree. Until recently Amarin had managed to maintain an exclusive arrangement with CVS. I/we don't know how they did that. This leads me to believe that we can compete with the generic companies. Pharmacy benefit managers are cutthroat. We still have other PBM agreements that are intact. It's possible that we could regain our exclusive contract in the next negotiation cycle.
Sleven,
North, Pharmacy benefit managers are under some scrutiny at the moment. They control the prescription drug trade in our country. It is debatable if they actually benefit the consumer in any way. I'll see what I can find concerning how they negotiate with "manufacturers". I'm not sure what I'll find. These organizations are immensely powerful. I would imagine that they make the major South American drug distributors jealous.
Sleven,
RMB, I don't have access to a signed contract between CVS and a generic manufacturer. I would be surprised if anyone could find that. It is possible that multiple generic companies could have engaged in a form of collective bargaining. That is beyond the scope of my knowledge. My point still stands. A PBM will provide the product that offers them the best profit. I am speaking simply about a complex financial system. Just calling our product a generic isn't going to provide CVS with a financial incentive.
Sleven,
Meowza, If they enroll that study I'll be happy to participate. I haven't had good cocaine since 85.
Sleven,
North, That is an entirely different issue.
Sleven,
Zip, The product that Amarin is selling is icosapent ethyl. Brand or generic doesn't change the cost. If Amarin wants to compete with the generic companies for the US market they need to cut a better deal with the pharmacy benefit managers. They don't care what we call our product.
Sleven,
RMB, I am certainly no authority on pharmacy benefit managers. I have little more than a general understanding of the prescription drug market machine. "Pharmacy benefit managers negotiate drug prices with manufacturers and pharmacies to help lower prescription drug costs for health plans." That is the simple Disney land explanation of what a PBM does. For the sake of this discussion let's use that and not go deep into the shady shit they actually do.
CVS Care Mark recently negotiated a deal with one of our generic competitors. Hypothetically let's say it was Teva. Brand Vascepa has been removed from all related formularies, and replaced with GV. The product that is going to be supplied by the manufacturer who negotiated the deal. If in this example Teva struck the deal with CVS, that PBM is not going to be supplying the generic manufactured by Hikma. This is the reason that it would not benefit Amarin to release an authorized generic. When we offered CVS the best deal they sold only our product. The game we are currently playing is all about pricing. Recently one of the people on this board said that the code B4G appeared on a CVS related formulary. The most common reason I could find for this was a supply shortage by the generic manufacturer. This fight for control of the US market is far from over.
Sleven,
RMB, Enjoy the vacation.
Sleven,
RMB, How would an authorized generic do anything that would effect the current US market situation?
Sleven,
MA52TA, It's not off label. Vazkepa is approved for sale. It's just not reimbursed.
Sleven,
Kiwi, Don't know about Italy. Was an AIFA meeting this week.. Vazkepa was on the agenda.
Sleven,
Nuke,, We just received our preliminary HTA assessment in Ireland. Now we need to respond. This was a different drug going through the process. You can see that there is a fairly quick back and forth toward the end.
Sleven,
https://www.ncpe.ie/fenfluramine-fintepla-for-lennox-gastaut-syndrome-hta-id-23051/
This provides a timeline for moving forward in the HTA process.
Sleven,
Captain, Thanks.
Sleven,
JRoon,
https://fdaaa.trialstracker.net/trial/NCT02719327/
I understand that the data has been submitted. It has not been reported. There is a reporting deadline.
Sleven,
North, I think the deadline is midnight on the 28th or 29th.
Sleven,
Antibluechip, Did a quick search on the B4G formulary code. Most common reason that this is done seems to be inadequate generic supply.
Sleven,
North, I haven't.
Sleven,
Kiwi, Does your logic also hold for off label generic prescriptions?
Sleven,
Laurent, Thanks.
Sleven,