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https://www.pacermonitor.com/public/case/40022951/DR_REDDYS_LABORATORIES_INC_v_AMARIN_PHARMA,_INC_et_al
This looks like it might be important. Can anyone provide details?
Sleven,
RMB, You might want to do a bit more research. What are the current requirements for approval of an Alzheimer's drug in Preclinical patients? When did FDA make the guidance change? When was the study started? How many patients are required for a successful biomarker study? What is the primary endpoint for BRAVE? Is there any evidence of the effects of icosapent ethyl on that endpoint?
Sleven,
BBI, Study results will be what they are. If they are positive it will be materially important. Prior science suggests the results should be positive.
Sleven,
BBI, Thanks for the response. EVAPORATE is the only clinical trial in your list that has any relevance to BRAVE. The primary endpoint for BRAVE is change in cerebral vascular blood flow. EVAPORATE, along with many other studies, suggests that the result will be positive.
Sleven,
RMB, If you wouldn't mind, can you take me through the logic that leads to your opinion?
Sleven,
BBI, Is it your position that BRAVE is unlikely to have a positive readout?
Sleven,
Zman, This is all related to the flaw in Hatch Waxman. The health net suit shows the weakness of the providers position. I don't know about consumer fraud. It certainly is induced infringement.
Sleven,
Zman, Insurance providers are the weak link. As the legal landscape stands, preferable coverage of the generic is an act that proves inducement.
Sleven,
ORBAPU, Agreed. This is years away, if not decades. This doesn't represent competition in any meaningful way.
Sleven,
ORBAPU, What is your definition of future?
Sleven,
Nuke,
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4439182/
I found a few minutes. Let me know if there is anything more about the cognitive testing your interested in.
Sleven,
Nuke, I'm out right now, but when I get back home I should be able to provide you with some information.
Sleven,
Laurent, Good find. More evidence supporting the link between icosapent Ethel and cognitive function.
Sleven,
Captain, Thanks for the numbers.
Sleven,
RMB, wow
Sleven,
Kiwi, I'm going to reply to your post, but I'm not going to be drawn into a conversation. It's unimportant. The study is about biomarker changes. It's not about effect on disease. Will icosapent ethyl have a positive trretment effect for Alzheimer's disease? I have no idea. My research has been focused on the biomarkers. That's it.
Sleven,
JRoon, No. That's not what I'm saying. Do you remember when you told me that the appointment of PWO to Charmin of the board was obviously the work of Alex Denner. I told you that there was no evidence of that. I believe you told me my head was in the sand. All that I am saying is don't make leaps that aren't supported by information.
Sleven,
JRoon, You are. You just don't understand that you are. We know that icosapent ethyl has a positive influence on the biomarkers in the study. The genetic markers could suggest that in that patient population icosapent ethyl doesn't slow the progression of disease. It doesn't say anything about biomarkers of disease. You are making hypothetical leaps that aren't represented by the information we have. You've done this before.
Sleven,
JRoon, Don't invent things. Icosapent ethyl has already been shown to have a positive effect on all of the biomarkers being studied.
Sleven,
Laurent, Thanks. I don't think this issue is likely to have any impact on the BRAVE study. The change in biomarkers shouldn't be effected by genetic markers. I would have concerns if this was a long term outcome study. The development of disease is not part of BRAVE.
Does that make sense to you?
Sleven,
Laurent, I think I understand now. Am I correct that the German paper was about the effects of omega 3 fatty acid on disease progression?
Sleven,
TCI1, Laurent, I don't think I understand your concerns over patients in the study having this genetic marker.
Sleven,
Ramfan, I have poor Internet service where I live. My laptop is almost useless. Phone gives my eyes quiet a workout. As far as AI goes I want nothing to do with any of it. It's almost as if whoever developed these tools, and released them onto the net, never watched a sci-fi movie.
Sleven,
Ramfan, In some ways I really am a Luddite.
Sleven,
Monk, I had to look around for a bit before I found that I had the option to post a bull or bear emoji. I do all of my research and communication from my cellphone so I must have hit that by accident.
Thanks for letting me know.
Sleven,
Zip, I agree. Assuming the study is successful, I would think a reasonable doctor would put any patient on icosapent ethyl if they had a family history of Alzheimer's disease. Especially with the side bonus of prevention of CVD and stroke.
Sleven,
IOMT, Go into the link I posted to you from the Alzheimer's association. Scroll down to the circular chart. Icosapent Ethel is listed on the lower right center in purple. They consider it to be a phase 3 study. This isn't the only site that lists it that way.
Sleven,
Pdude, I agree. An improvement in cerebral blood flow is the trials primary endpoint. EVAPORATE has already demonstrated the ability of icosapent ethyl to do this.
Sleven,
Zip, Sorry to hear about your family member.
Sleven,
Laurent,
https://www.statnews.com/2018/03/05/alzheimers-disease-drugs-fda/
This is a good quick read. It explains the the recent shift in guidelines.
Sleven,
Kiwi, Thanks for the audio. What is your point?
Sleven,
Laurent, I have no idea what clinical research would look like post BRAVE. Are you familiar with the most recent FDA guidelines for an Alzheimer's disease drug approval? Preclinical has the lowest bar for an indication. Positive effect on biomarkers. It is unclear if damage done during disease progression is reversible. This might be why FDA stratified the evidentiary requirements. How would you construct a large long term study on preclinical patients?
Sleven,
Zip, I agree. If this study is successful it would meet the newly released guidelines for drug approval. Guidelines for Preclinical patients.
Sleven,
Kiwi, You are welcome to your humble opinion. In this I am going to go with the written opinion of FDA.
Sleven,