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Captain, Thanks for the numbers.
Sleven,
RMB, No AD drugs have been approved for the preclinical patient category. I posted a list of the 6 that are currently in clinical trials. If you like I can look for the list and repost.
Sleven,
Captain, That is all correct. The FDA change of opinion caused the problem with ANCHOR. FDA now considers certain biomarkers to be surrogates for AD drug approval. The Alzheimer's drugs that are being approved at the moment are because of biomarker changes.
Sleven,
Kiwi, interesting read. I don't believe this new hypothesis should have any effect on how FDA is currently thinking.
Sleven,
Kiwi, Thanks I read the highlights. The body of the article will need to wait till I get home.
Sleven,
Kiwi, I have no idea what Amarin, the university of Wisconsin, or the VA think. I am not aware of any public statement on the subject.I learned a lesson from ANCHOR. Now I both monitor the science of the study, and track the most recent FDA guidelines. The only opinion that matters is the one posted by FDA.
Sleven,
Kiwi, Yes. In short FDA changed their guidelines after the study began. Alzheimer's disease guidelines were changed after the start of BRAVE. At the moment according to the most recent guidance posted, a positive change in biomarkers of AD is enough for accelerated drug approval. For Preclinical patients.
Sleven,
RMB, Do you remember what happened with the ANCHOR clinical trial, and the SPA associated with it?
Sleven,
Golf, I don't know. If anyone on here has a background in clinical trials or government funding I would be interested in opinions.
Sleven,
DMC, Thanks for the information. The project is listed as running from July 2016 - March 2024. No funding for 2024. This gives us some ideas about when to expect results.
Sleven,
DMC, 23-11-2023 9:00am
Sleven,
Lizzy, Madrid. Capitol of Spain. Hiring there should be expected. We have both marketing approval and a successfully negotiated reimbursement.
Sleven,
DAR, I am heavily invested as well.
Good luck.
Sleven,
DAR, The decisions that Amarin made to increase staff in the USA and Germany were appropriate at the time. The patents should not have been invalidated in the US. Germany changed the rules mid launch. If you have any interest in knowing how close we are to reimbursement in European countries, follow the jobs. They ramped up hiring in Spain one to two months prior.
Sleven,
Lizzy, Yes. My point as well.
Sleven,
Lizzy, Germany changed the rules after we hired our people. Portugal is a different situation.
Sleven,
Lizzy, I think you're missing my point. We are hiring more people in EU countries where we have reimbursement agreements. That makes sense. Why Portugal?
Sleven,
Lizzy, Yes. Amarin is approved to sell vazkepa in Portugal. Without reimbursement it doesn't really matter. In the last two days quite a few jobs have popped up for that county. I think it's reasonable to assume that the company believes they are going to need people there soon.
Sleven,
Lizzy, Have we reached a reimbursement agreement with Portugal? If we have, I'm not aware of it.
Sleven,
Jasbg, Hiring in Portugal?
Sleven,
North, Wisconsin alumni research foundation. I assume that is WARF.
Amarin is in no position to fund a large outcome study, so someone like them would need to step in and provide funding.
Sleven,
Laurent, I agree with everything you just wrote. I think an outcome study would be far too expensive at the moment. If the government wanted to fund it that would be different. A positive result from BRAVE followed by the companies lack of willingness to conduct an expensive outcome trial might also shine a light on the flaws in the implementation of the "skinny label". I doubt any of our generic competitors would fund a study.
Sleven,
Laurent, Why run an outcome trial?
Sleven,
Jasbg, You are in the lead.
Sleven,
Zip, Edding can't resell product that they buy from Amarin. Amarin is the only entity with approval to distribute icosapent ethyl in Europe. This is not something you need to worry about.
Sleven,
Captain, Thanks for the numbers.
Sleven,
Zip, Who are these middle men, and how would they be involved?
Sleven,
Captain, Thanks.
Sleven,
JRoon,
https://www.cmocro.com/news_detail/EPADEL+China+Clinical+Trial+Initiation+Notice/312788/index.html
To the best of my knowledge, the clinical trial that is needed to apply for the Chinese approval of epadel is still ongoing.
Sleven,
JRoon, What is that link telling us?
Sleven,
Zip, I don't understand your supply question?
Sleven,
Captain, I don't believe epadel is currently approved for any indication in China.
Sleven,