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Kiwi,
https://clinicaltrials.gov/study/NCT01047683?term=Vascepa&rank=1&tab=results
Check the actual enrollment.
Sleven,
Kiwi, Yes. I should have chosen my words more carefully. The number of patients in the study should be irrelevant, when/if FDA is reviewing the results.
Sleven,
IOMT, I agree. This is where I defer to the judgement of Dr Carlson.
Sleven,
Zip, The only criticism of this study I have seen comes from this board. The size of the study is irrelevant. What matters is the p value of the results. I have no doubt that Dr Carlson enrolled the appropriate number of subjects to produce relevant data. This study is not designed to show any effect of the drug on disease. It's a biomarker study.
Think MARINE and ANCHOR, not R-IT.
Sleven,
Zip, No arguments. The primary focus of the study is cerebral blood flow. Secondary measures involve biomarkers in spinal fluid. My point is that the design of this study should produce analog results. These surrogate endpoints are effected or they aren't. I have done research into the clinical work that this trial is based on. What I found suggests a strong likelihood that the primary endpoint should be achieved. Secondary endpoints also have a good chance. Either way this is not the sort of trial that shows a "trend". The results should be conclusive yes or no.
Sleven,
Zip, I do agree with you about the apparent Amarin strategy to undercut the wholesale price of generic competitors in the US market. This started under prior management and continues today. At the moment this strategy is putting pressure on our margins. If we can reduce our unit cost for API, margins should improve. I also agree that generic companies won't be able to compete effectively. I have believed that this was the strategy to deal with generic competitors since the first announcement of the exclusivity contracts. I think this approach has a good chance of success. I continue to accumulate shares because of that view.
As far as the BRAVE study, I disagree with your thinking. This is not a study design that will conclude showing some sort of a trend. It will/won't show an effect on the biomarkers that indicate disease. This is not an outcome study. The patients in the study are Preclinical.
Sleven,
Bouf, I understand your skepticism. The generic companies purchase API. They don't produce it. If Amarin can continue to open non US markets they should be able to establish a pricing advantage in the US. If a cheaper production method is discovered it wouldn't necessarily provide either side advantage.
Sleven,
Golf, Laurent, On November 1st I received an email from Hannah Zylstra. (BRAVE study coordinator) She was responding to my request for information about the study. She informed me that all of the data had been collected, but was still being processed.
Sleven,
Bouf, Three years after the entry of the first generic and we still hold the majority of the market. Why is that? This is not a drug that can be produced In mass cheaply. The standard generic playbook doesn't work on this. Amarin has been able to compete. The market will grow over time. Generic companies will most likely have their piece and we ours. What the potential size of that market will be is key for determining the success of our investment.
Sleven,
Bouf, As long as the courts interpret the Hatch Waxman act, as an act that negates method of use patents there is no way to keep them out of the US market. The generic companies have been unable to take the US market for CVD. Not for lack of trying. Their presence has damaged the market and prevented growth.
Sleven,
Bouf, Alzheimer's disease is global. Few treatment options are available.
Sleven,
Captain, Thanks for the numbers.
Sleven,
Skipper, No problem. Europe is painfully slow.
Sleven,
CBB, You don't need to try to sort this out in your own head. Google icosapent ethyl+pharmacokinetics. You will find out exactly how Vascepa is absorbed by the body. The lymph system is involved in the current formulation. I posted this information here. Recently. After you read and understand, you can compare this information with the information in the "self emulsifying" patent.
Sleven,
CBb, How do you think the current formulation of Vascepa is absorbed by the body?
Sleven,
Monk, I posted this because the similarities between the launch of the first statin and Vascepa. Including a pair of doctors making fictional side effect claims. (Sound familiar) Doctors are not prone to rapid changes. The markets need to reach a tipping point. This process starts with clinical research MD 's. Then it trickles down to the specialist. Eventually it works it's way down to the general practitioner. This process requires time. Statin medications didn't have an explosive start. Neither have we. In the absence of other options, this is just a matter of time.
Sleven,
JRoon, I can't speculate as to the reason. The math doesn't work.
Sleven,
JRoon, I think that is correct. When you check the shipping records you need to be careful. Often the company that is doing the encapsulateing receives the shipments. What I find most interesting is the quantity of API being purchased by Teva. They aren't selling enough finished product to support those purchases.
Sleven,
Denisk, I have provided the board with two websites that will allow those who are interested to track the appeal. All you need to do is open the files and read them. That's a minimal effort.
Sleven,
Zman,
https://cafc.uscourts.gov/home/oral-argument/scheduled-cases/
Keep an eye on this site for oral arguments to be scheduled.
Sleven,
North, Thanks. I have the data for storage and expiration of encapsulated product. I'm interested in expiration of API still in the nitrogen filled steel drum. I am assuming that our long term inventory has not yet been encapsulated. I don't know that this is the case.
I have recently been in contact with Carlson labs. The BRAVE study has concluded, and the data is being processed. They told me that they would update clinical trials. Gov when they were done with their evaluation.
Sleven,
Tat, Thanks for the reply. I was actually on this page before. I couldn't find anything definitive about the shelf life when it was in a refrigerated nitrogen filled barrel. There is a retest timeline of 36 months.
Sleven,
Does anyone here have information on the shelf life of API that hasn't been capsulated?
Sleven,
Twin,
V 62,814
Gv 47,767
L. 68,806
Sleven,
Laurent, Thank you for staying on top of this. It's appreciated.
Sleven,
Laurent, How did the patent battle end?
Sleven,
JRP, Sounds like Amarin disagrees with DRL's view on their lack of participation in the mitigation process.
Again thanks.
Sleven,
JRP, Thanks.
Sleven,
Laurent, understood.
Sleven,
Laurent, Given the exclusivity period, what would be the point in trying to break this patent?
Thanks.
Sleven,
Laurent, Good news. Thanks for tracking this.
Sleven,
JRoon, I don't know what the legal strategy is in the Sherman act suit. Not for either side. The generic companies want something. What? They don't have enough sales to require more supply. Amarin just declared that they have no interest in the court ordered mediation. By doing this they have made a statement. They are defying the judge. Fairly bold. They could have given authorization to negotiate and not excepted terms. That would have been a more vanilla approach. The mediation stage has concluded. This is back to court.
Sleven,
JRoon,
https://www.courtlistener.com/docket/59859757/dr-reddys-laboratories-inc-v-amarin-pharma-inc/
Read the letter. The attorneys for Amarin were not unprepared. They were not granted the authority to negotiate. That is a statement. Good or bad, Amarin clearly had no interest in this pathway towards resolution. Mediation is over.
Sleven,