jfmcrr
2 hours ago
Orbapu,How did your brother make out on Vascepa through all that? I have a friend who recently went thru the same, and I'd like to forward any good outcomes your brother had. Thanks
May 2020; One stent Friday night, (100% blockage) two stents Monday, (70% blocked) Vascepa before during and after. No untoward bleeding, no damage visible on complete cardiac image work up.
Whalatane
4 hours ago
Snd. The issue is gaining reimbursement for at least a subgroup of the R-IT trial .
Does Germany consider Real World data in this decision ?[I]
Yes, the German health system uses real-world data and analysis when considering reimbursement for drugs. Real-world data (RWD) refers to data collected outside of traditional clinical trials, often from sources like electronic health records, insurance claims, and patient registries. This data is valuable for evaluating how treatments perform in real-world settings, including their effectiveness, safety, and cost-effectiveness.
In Germany, the Federal Joint Committee (Gemeinsamer Bundesausschuss or G-BA) plays a crucial role in determining which medical treatments, including drugs, are reimbursed by statutory health insurance funds. The G-BA assesses the clinical benefit of new drugs based on evidence from clinical trials as well as real-world evidence when available.
Real-world evidence can provide insights into how drugs perform in everyday clinical practice, including their impact on patient outcomes, adherence rates, and healthcare utilization. This information is valuable for decision-makers when evaluating the value of a drug and determining its reimbursement status within the German health system.
Overall, while clinical trial data remains essential for drug evaluation, real-world evidence complements this by providing a broader understanding of a drug's real-world impact, helping to inform reimbursement decisions in Germany's healthcare system.[/I]
So if AMRN isn't going to cosponsor a small trial ...which almost everyone here is adamantly against ...at least dig up some Real World data that they would accept
Kiwi
Snd101
4 hours ago
Kiwi, the idea of collaborating with a nation’s healthcare org to design and run trials is very productive. And as you said it happens so many times and in so many places. That’s a raw fact, there is no interpretation to it. The real question is what is the objective of the trial? Now taking it in the context of Amarin if the objective of the custom trial is to re-verify the “reduce-it” outcome, then I don’t think it makes any sense for Amarin to collaborate with them in any ways. If they don’t like reduce-it results, it’s on them. Amarin funding a trial to re-evaluate reduce-it results for them is basically telling the world it has doubts on its own landmark reduce-it trial. But if Germany, France or Italy want to collaborate with Amarin to run a powerful trial for any other indication for example AD, then it would be a different conversation. Amarin might have vested interest in that.
Whalatane
6 hours ago
The issue is gaining reimbursement in Germany ( and Italy and France )
EU Pharma Co's co-sponsor trials with the German Health Dept all the time
When pharmaceutical companies co-sponsor drug trials with German health departments, several steps and processes are involved:
Protocol Development: The pharmaceutical company and the health department collaborate to develop a detailed protocol outlining the objectives, methodology, participant selection criteria, treatment procedures, and endpoints of the clinical trial. This protocol must adhere to German regulatory requirements and ethical guidelines.
Regulatory Approval: Before initiating the trial, the protocol must receive approval from regulatory authorities such as the Paul-Ehrlich-Institut (PEI) or the Federal Institute for Drugs and Medical Devices (BfArM) in Germany. The pharmaceutical company typically submits the protocol for review, and the health department may provide input or support during this process.
Ethics Committee Approval: In addition to regulatory approval, the trial protocol must be reviewed and approved by an independent ethics committee (EC) in Germany. The EC ensures that the trial design is ethical, respects participants' rights, and prioritizes safety.
Trial Conduct: Once approvals are obtained, the pharmaceutical company and the health department collaborate on various aspects of trial conduct. This includes recruiting participants, administering treatments according to the protocol, collecting data, monitoring participant safety, and managing any adverse events.
Data Analysis and Reporting: After completing the trial, both parties work together to analyze the data collected. This analysis aims to assess the safety and efficacy of the investigational drug. The results are then compiled into a comprehensive report, which may be submitted to regulatory authorities for marketing authorization.
Post-Trial Follow-Up: Even after the trial concludes, the collaboration between the pharmaceutical company and the health department may continue. This may involve follow-up studies, post-marketing surveillance, or further evaluation of the drug's long-term effects.
Kiwi
ORBAPU
9 hours ago
The old bleeding canard.
My brother got 6 stents. Simultaneous catheterizations, groin and arm, two cardiologists. On Vascepa before, during, and after. Procedure included Atherectomy on some blockages plus use of impella pump.
I had double hernia surgery, the old way, not robotic. On Vascepa. And yes, I disclosed pre surgery medications. No bruising and rapid recovery.
antibluechip
9 hours ago
Kiwi, I did not have stents in spite of 3 blockages in the 65-70 percent range plus Type II. In 1972, Cardio said my blockages were at the borderline and he was willing for me to go with Crestor(later Pitavastatin) , diet, exercise, no blood thinner.
A month later in dicussion with my GP, I mentioned I was eating a can of sardines every day for lunch, just because I thought it would be good for my heart. He said, "let me give you something to take so that you don't have to smell those sardines every day." And he prescribed Vascepa. (I've often wondered if an Amarin Rep had just left his office before my appointment-I doubt he was prescribing from data, just "no smell")
Dave
Snd101
9 hours ago
Thanks for sharing your thought process. I agree that approval by France, Germany and Italy is one of the major keys to success for Amarin. Is the path to get there is via running custom trial that these three country would like? I am not so sure. It would be a surprise if those three countries agree to a common clinical custom trial. Even if they do it’s not an binding agreement that they have have to act according to the trial outcome. Government changes, health dept official changes. Running a custom trial to satisfy a specific health official defeats the purpose of running a trial to get FDA approval. It’s sets a wrong precedent. It basically makes the process of inventing new medicine and commercializing it at scale unsustainable. I am sure there are other more efficient methods to provide answers to the technical/medical queries of these health officials. If that is really blocking them for accepting the drug. But I believe the real reason for these health officials is not the concern about the medicine itself, but it’s something else. They are just using the data about the medicine as a false wall. You run a trial and alleviate their concern, they will come up with another concern. So no matter what trials you run for them, it’s going to be the same story. Bottom line is addressing the real reason behind their hesitance to embrace the drug and I believe Amarin is working to address that instead of jumping in to start another trial to satisfy them. My thoughts.
JRoon71
9 hours ago
MDC, I think about 7 out of 10 of those fit Amarin to the T.
But this one certainly seems most likely to be what Denner is trying to pull off::
4. Large amounts of phantom premium are on the table.
Buyouts usually come with large premiums. The question is, how much of that premium is real, and how much is phantom? (Fake.)
In a free market, if your stock is trading at $100, and the buyout is $150, that's a 50% premium.
But in today's market, Wall Street is more likely to smash your stock down to $75, and then organize a merger at $150. ($50 real premium, $25 phantom.)
This creates an illusion that your stock is being given a 100% premium.
Denner is most likely trying to show the "$1 to $10 rise" that they managed, ignoring the fact that this stock was at $9 right before Sarissa started buying (coincidence??). I am about 99% certain that Sarissa has been behind much of the shorting the past few years that has driven the price down.
antibluechip
10 hours ago
Kiwi, Excellent Proposal and Instruction on Power/Significance.
Along the same lines, do you think there are enough of us who have been on Vascepa for 5 years or more( typically after some intervention or detection), that could form the basis for a "post analysis" of subsequent "heart events," "plaque change," or similar markers? And I suppose a comparative non-Vascepa group could be identified easily.
As an example, I have been on V for 10 years after a CT scan and Heart Catheterization showed 3 serious blockages. As a researcher, I have always been hoping for a followup Heart Cath to see what if anything has changed. But cardios don't do a followup Heart Cath unless you present symptoms. Seems that individuals in my situation would yield some valuable data for just the cost of a 2nd Heart Cath. And of course others like me who ended up with stents, would seem to be an even larger group of candidates.
Thoughts, Ideas?
Dave
Whalatane
10 hours ago
Snd. Here's an example of a clinical trial actually run by the German Health Dept
Short trial. ... 1 year
https://pubmed.ncbi.nlm.nih.gov/31475799/
Conclusions: Among patients who presented with acute coronary syndromes with or without ST-segment elevation, the incidence of death, myocardial infarction, or stroke was significantly lower among those who received prasugrel than among those who received ticagrelor, and the incidence of major bleeding was not significantly different between the two groups. (Funded by the German Center for Cardiovascular Research and Deutsches Herzzentrum München; ISAR-REACT 5 ClinicalTrials.gov number, NCT01944800.)
MI and stroke significantly lower but no increase in major bleeding .......run a similar trial with Vazkepa
Kiwi
Whalatane
10 hours ago
Snd. We need meaningful reimbursement in Germany , France and Italy . If I was the Ceo of AMRN I would try to engage those Health Depts in discussions on designing a clinical trial that if successful would make them commit to at least cover the selected population studied in the trial .
An obvious R-IT subgroup IMHO is the revascularisation subgroup . Event lines separated fairly early
Theres no placebo . We would compare existing SOC ( standard of care ) with SOC plus Vascepa and look at the revasc rates following the initial PCI procedure
In R-IT , these revasc rates were cut by roughly 50% ........so a major savings in healthcare costs to these Health Depts .
Again ...we need the buy in from these 3 health depts in at least designing , organizing and if necessary running this trial ...say as Kaiser ran MITIGATE. here in the US.
The trial has to be large enough ( properly powered ) so that these Health Depts agree will act on the results if the risk reduction is clinically relevant and statistically significant. The Greek trial Capt referred to is " hypothesis generating " .
Its important to understand how clinical trials are powered to get health depts to act on the results
Power is critical in clinical trials because it helps determine the ability of a study to detect a true effect if it exists. In other words, it measures the likelihood that the study will correctly identify a treatment effect when one truly exists, as opposed to mistakenly concluding that there is no effect (a false negative) or incorrectly concluding that there is an effect when there isn't (a false positive). Here are a few key points about the importance of power in clinical trials:
Statistical Significance: Power is closely related to statistical significance. A study with low power may not detect a true effect, even if one exists, leading to a false conclusion that the treatment is not effective. On the other hand, a study with sufficient power has a better chance of detecting a true effect if it's present.
Sample Size Determination: Power analysis is used in the design phase of a study to calculate the sample size needed to achieve a desired level of power. This calculation considers factors such as the expected effect size, variability of the data, and the desired level of statistical significance.
Ethical Considerations: Conducting a study with low power can be considered unethical because it may involve exposing participants to potential risks without the ability to generate meaningful results. Adequate power ensures that the study has a reasonable chance of answering its research question.
Resource Utilization: Clinical trials are resource-intensive, involving time, money, and human resources. Conducting underpowered studies can be a waste of these resources, as they may not provide reliable answers or contribute significantly to scientific knowledge.
Regulatory Approval: Regulatory agencies often require studies to have adequate power to detect clinically meaningful effects. This requirement ensures that the evidence generated from trials is robust and can support decisions regarding the safety and efficacy of interventions.
In summary, power is crucial in clinical trials because it influences the reliability and validity of study results, ethical considerations, resource utilization, and regulatory acceptance. A well-powered study is more likely to provide meaningful insights and contribute to evidence-based decision-making in healthcare.
Bottom line ...Ypu need these EU health depts to buy into this trial in some form ( AMRN may fund it but the Health depts have input on design and actually run the trial ........short trial ...max 3 yrs if possible and if properly powered )
Kiwi
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