Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Jbog. re your comment
RGLS . I have a small position in this Co
Reasons for my position ?
Theres currently only 1 med available specific to ADPKD kidney disease and its poorly tolerated ( makes you pee a lot ) and not very effective.
There are around 160,000 ADPKD patients in the US and around 55% of them will have kidney failure and need dialysis by age 55.
My wife rounds dialysis clinics and writes reports on roughly 120 dialysis patients each month ..There is a high mortality rate for dialysis patients ...you can google or perplexity the numbers if you wish.
RGLS 's med slows the formation of cysts in the kidney filtration system and so far appears very safe and well tolerated.
This is P 1 data . P2 trials expected in 2025 will an expected application for accelerated approval .
So early days
Vivo Capital owns roughly 8% of the outstanding shares ( IIRC ) . Vivo specializes in a lot of niche kidney specific drugs in development ...UNCY for example
Kiwi
RMB. Thx ...Theres a lot of research going on in CKD . OT I've been doing some research on RGLS which has published some interesting clinical data recently
Kiwi
Thx Jbog Just to be clear ...and it's none of my business so ignore if necessary ...the cysts were liquid filled ? I thought that was one of the markers of ADPKD
In case anyone should venture here
Whalatane
Member Level
Re: None
Monday, May 13, 2024 6:59:02 PM
Post# of 251809
UNCY pivotal trial update
“This is an exciting time for Unicycive as we progress towards the conclusion of our pivotal clinical trial for our lead asset oxylanthanum carbonate (OLC),” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The trial is evaluating the tolerability, safety, and pharmacokinetics of clinically effective doses of OLC in patients with chronic kidney disease (CKD) on dialysis and it remains on track with topline data expected later this quarter.
UNCY pivotal trial update
“This is an exciting time for Unicycive as we progress towards the conclusion of our pivotal clinical trial for our lead asset oxylanthanum carbonate (OLC),” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The trial is evaluating the tolerability, safety, and pharmacokinetics of clinically effective doses of OLC in patients with chronic kidney disease (CKD) on dialysis and it remains on track with topline data expected later this quarter.
From ER
“This is an exciting time for Unicycive as we progress towards the conclusion of our pivotal clinical trial for our lead asset oxylanthanum carbonate (OLC),” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The trial is evaluating the tolerability, safety, and pharmacokinetics of clinically effective doses of OLC in patients with chronic kidney disease (CKD) on dialysis and it remains on track with topline data expected later this quarter.
Newman. My guess is that its positioning in advance of the expected UK approval of the share buyback
Share buybacks can positively impact a company's stock price through several mechanisms:
Increased earnings per share (EPS): By reducing the number of outstanding shares, the company's earnings are divided among fewer shares, resulting in a higher EPS. A higher EPS can make the stock more attractive to investors and drive up the share price.
Increased demand: When a company repurchases its own shares, it creates additional demand for those shares in the market, which can lead to an increase in the stock price.
Signaling effect: Share buybacks can be interpreted by investors as a signal that the company's management believes the stock is undervalued. This positive signal can boost investor confidence and drive up the stock price.
Increased ownership stake: As the number of outstanding shares decreases, the remaining shareholders' ownership stake in the company increases proportionally. This can make the stock more valuable to investors.
Improved financial metrics:
Share buybacks can improve financial metrics such as return on equity (ROE) and return on assets (ROA), making the company more attractive to investors and potentially increasing the stock price.
Vin re RGLS . I have a small position in this Co and am also interested in why Jbog is high on it ?
Reasons for my position ?
Theres currently only 1 med available specific to ADPKD kidney disease and its poorly tolerated ( makes you pee a lot ) and not very effective.
There are around 160,000 ADPKD patients in the US and around 55% of them will have kidney failure and need dialysis by age 55.
My wife rounds dialysis clinics and writes reports on roughly 120 dialysis patients each month ..There is a high mortality rate for dialysis patients ...you can google or perplexity the numbers if you wish.
RGLS 's med slows the formation of cysts in the kidney filtration system and so far appears very safe and well tolerated.
This is P 1 data . P2 trials expected in 2025 will an expected application for accelerated approval .
So early days
Vivo Capital owns roughly 8% of the outstanding shares ( IIRC ) . Vivo specializes in a lot of niche kidney specific drugs in development ...UNCY for example
Kiwi
Chromosome , isn't the market in Canada split between Cardiologists and Primary Care with PFE only marketing to Primary Care ?
It would seem that since the R-IT trial was mostly secondary prevention CAD patients ...Cardiologists would be the main market .
Primary Care have enough trouble keeping their CAD patients on Statins which are very low cost and in the case of Crestor at least ...small pills and only once a day .
Secondary prevention patients ( prior MI , stroke etc ) are probably more willing to add 4 large caps to their daily med routine .
But IMHO all this is largely irrelevant to AMRN's bottom line .
Their main challenge is to gain more reimbursements in the EU and ramp up sales there before US revenue declines any faster then already seen in Q1 numbers
Kiwi
Nope ...good news for the new weight loss drugs
Now if Vascepa could be proven to reduce obesity ...then you're talking
Kiwi
Ram. it typically takes 1-5 yrs to get a patent on a drug . You're dealing with prior art and USPTO actions .
IIRC in the 2010 / 2011 period the patent office originally rejected the Marine patent . Eventually it was approved because AMRN could prove that Vascepa ( AMR101 at the time ) was DEVOID of DHA . Epadel by contrast has up to 10% DHA .
Poster North may have a better memory of this period.
AMRN doesn't have this time if they continue on their current path and especially if they use $50m on a share buyback.
The reality is that revenue in the US is crashing and revenue growth in the EU is minuscule .
And so far mgt has yet to come up with an effective plan to convince the market , they can change that .
Which is why the PPS is under $1.
JMO
Kiwi
Because Dr Ketchum probably knows this already ...and knows AMRN will not spend time and $ on pursuing this since for one thing they would need to prove it better than an EPA/DHA combination .
A network meta-analysis study provided compelling evidence that high-dosage EPA/DHA (omega-3 fatty acid) supplementation can be considered a first-choice treatment for migraine prophylaxis.
Another study found that high-dosage omega-3 fatty acids, including EPA/DHA, outperformed existing pharmacological options for migraine prophylaxis. The researchers concluded that EPA/DHA supplementation can be considered as a first-choice treatment for migraine prevention.
A review article discussed the potential therapeutic role of omega-3 fatty acids, including EPA, in the treatment of migraine through their anti-inflammatory effects. The review highlighted several clinical studies examining the use of omega-3 fatty acids, either alone or in combination with other substances, for migraine treatment.
In summary, the search results indicate that multiple studies have investigated the use of EPA, either alone or as part of omega-3 fatty acid supplementation, for the treatment and prophylaxis of migraine.
Capt. I believe thats a lot of Prior Art regarding Omega 3's and migraines ...so patent protection might be a challenge.
The exclusivity route ...see previous posts .
Great graphics tho
Kiwi
So I'll answer my own question about lack of patent protect for the migraine indication...exclusivity is an option
Based on the search results, the key differences between patents and regulatory exclusivity for drugs are:
Patents are granted by the U.S. Patent and Trademark Office and protect the intellectual property of the drug inventor, typically lasting 20 years from the filing date. Exclusivity is granted by the FDA upon drug approval and prevents competitors from submitting generic or similar versions for a specified period of time.
Patents can be obtained at any stage of drug development, while exclusivity only comes into play after the drug is approved by the FDA.
Exclusivity periods are typically shorter than patent terms, ranging from 3-12 years depending on the type of exclusivity (e.g. new chemical entity, orphan drug, pediatric).
Patents can be challenged and invalidated, while exclusivity is more secure and guaranteed as long as the statutory requirements are met.
Patents and exclusivity can run concurrently, but exclusivity often expires before the patent term ends. The expiration of the later of the two is what determines when generic competition can enter the market.
In summary, patents and exclusivity serve complementary but distinct purposes in protecting drug products, with exclusivity providing an additional layer of protection beyond just the patent term. The interplay between the two is complex but critical for understanding the timing of generic drug entry.
Capt. What would you have AMRN do with this info ?
AMRN doesn't have any patents covering composition or method of action for treating migraines that I'm aware of .
The trial was run using Epadel ...and it only enrolled 70 people using a drug not FDA regulated
Studies a U.S. FDA-regulated Drug Product: No
FFS. re this post
Combine that behavior with the noted indicator reversals and we have the TA ingredients for powerful move
Price. 0.8741
RMB. I think we are due for data from the LYNX trial
, Edgewise Therapeutics expects to report 3-month data from the Phase 2 LYNX trial for EDG-5506 in the second quarter of 2024. The LYNX trial is a Phase 2 dose-ranging study to evaluate the safety and efficacy of EDG-5506 in patients with Duchenne muscular dystrophy (DMD).
Prior Art on EPA for Migraine Relief
A 12-week randomized, single-blind clinical trial found that dietary supplementation with fish oil, which contains EPA, led to a reduction in the number of headaches per month in patients with chronic migraine. The authors suggest this beneficial effect could be due to decreased production of pro-inflammatory molecules like prostaglandins, leukotrienes, and cytokines.
A randomized controlled trial published in The BMJ in 2021 looked at 182 people with chronic migraines. Participants on diets high in EPA and DHA (1.5 grams total per day) from fish had 30-40% fewer headache days per month and headache hours per day compared to those on a control diet low in EPA/DHA.
Another study found that 2 months of supplementation with 1 gram of omega-3 fatty acids, which are primarily EPA, significantly decreased the frequency and duration of migraines, with patients reporting a 74% reduction in headache duration.
The mechanisms by which EPA may reduce migraines include its anti-inflammatory effects, modulation of pain-regulating oxylipins, inhibition of vasodilation, and reduction of nociceptive (pain) responses in the brain.
However, some earlier studies did not find a significant difference in migraine outcomes between omega-3 supplementation and placebo. Overall, the evidence suggests EPA from fish oil has promise as a migraine treatment, but more research is needed to confirm its efficacy.
Congrats on your Gr8 find / hold
Kiwi
They don't have any patent protection for use in treating migraines ( no method of action or composition of matter patents ) ...so I'm sure the generics and supplement Co's would love AMRN to waste time and $ on such a study .
Kiwi
Thx Dew. Do U use Perplexity at all ?
A quick search on the difference between Eyepoint and Ocular
Answer
Eyepoint Pharmaceuticals and Ocular Therapeutix are two different pharmaceutical companies focused on developing treatments for various eye diseases:
Eyepoint Pharmaceuticals is focused on developing sustained-release intraocular drug delivery products, including YUTIQ® for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye and EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment for wet age-related macular degeneration.
Ocular Therapeutix is a biopharmaceutical company developing transformational treatments that enhance vision and quality of life through consistent and sustainable drug delivery, including for retinal diseases, glaucoma, ocular surface diseases, and ophthalmic surgery.
The key differences are:
Product focus - Eyepoint is focused on posterior segment eye diseases like uveitis and wet AMD, while Ocular Therapeutix has a broader portfolio across retinal, glaucoma, ocular surface, and surgical applications.
Drug delivery technology - Eyepoint utilizes its proprietary Durasert® technology for sustained intraocular drug delivery, while Ocular Therapeutix has its own ELUTYX™ technology platform.
Commercialization - Eyepoint has two commercial products, YUTIQ and DEXYCU, while Ocular Therapeutix is still in the clinical development stage for most of its pipeline.
In summary, while both are ophthalmology-focused pharmaceutical companies, they have distinct product portfolios, drug delivery approaches, and stages of commercial development.
Here are some examples of real-world evidence (RWE) studies that supported the approval of drugs in the EU:
The European Medicines Agency (EMA) has published several case examples of how RWE was used to support marketing authorization applications for new products and extensions of indications submitted to the Agency in 2018 and 2019:
40% of initial marketing authorization applications contained RWE to support the applications.
18% of applications for extension of indication for products currently on the market contained RWE.
The report describes the characteristics of the RWE included in these applications, such as using electronic health records, claims data, and post-marketing safety reports to support clinical efficacy and safety in new patient populations.
Additionally, the EMA has conducted various pilot studies to explore the use of RWE to support regulatory decisions across its scientific committees and working parties.
Some examples of these RWE studies include:
Safety studies
Drug utilization studies
Disease epidemiology studies
Studies to inform the design and feasibility of clinical trials
Studies to support health technology assessment and payer decision-making
These EMA-led RWE studies have covered a range of therapeutic areas, with a focus on conditions diagnosed or medicines used in the primary care setting. The learnings from these pilots are helping to establish the value of RWE and identify the regulatory use cases where it can add the most value alongside traditional randomized clinical trials.
Examples of how the RWE studies were useful include: filling knowledge gaps, validating evidence submitted by companies, providing additional information like recent data or data from different regions, and conducting sensitivity analyses.
While most studies focused on conditions and medicines used in primary care, about a third of the research topics were not considered feasible due to limitations in the available data sources or procedural time constraints.
In summary, the search results indicate that EMA has actively leveraged RWE from its own studies and the DARWIN EU® network to support regulatory decision-making across various use cases, though some challenges remain in terms of data availability and timeliness.
Based on the search results provided, it does not appear that tax loss credits for a company registered in Ireland can be directly used by a company registered in the US. The key points are:
Irish resident companies are generally taxable in Ireland on their worldwide income and capital gains, with a credit available for foreign taxes paid.
Foreign taxes borne by an Irish resident company may be creditable in Ireland, with a system of onshore pooling of excess foreign tax credits available.
However, the search results do not indicate that tax loss credits from an Irish company can be directly utilized by a US-registered company. The tax systems operate independently.
The search results suggest that the tax treatment and ability to utilize tax credits is specific to the company's tax residency. There is no mention of a mechanism to transfer tax loss credits between an Irish company and a US company. The tax systems appear to be separate, with each company subject to the tax rules of their respective jurisdictions.
Chromosome And I completely agree with your analysis , assuming they mine the data Kaiser etc are accumulating .
Make the economic argument in the EU for the reasons you mentioned.
The RR in select subgroups such as Revasc doesn't have to be as high as R-IT in the RWE study ...it just needs to be clinically relevant and a cost effective use of the Health Dept funds. ...( ie The Health Dept will save Euros by reimbursing for the sub group studied )
Kiwi
So what would constitute a stronger dossier ...Real World Evidence studies that the previous mgt once floated ?
As you probably know ..Real World evidence studies rarely show the same degree of RR as the original trials.
This is well known and the reason is that in most CV trials the patients that enroll are often more health conscious than the general public and are more likely to adhere to the dosing schedule.
So knowing this you focus on that subgroup with the highest RR thats quantifiable and can easily translate into healthcare cost savings .
Even if the Revasc subgroup only showed a 20% RR vs the over 40% reported in R-IT ...its still a huge saving in healthcare cost .
Ask posters here who have had a PCI what they cost ?
My angiogram / angioplasty in 2016 was $18,000 ...no over night stay and no stents
This didn't include the ER costs ...just the Cath Lab costs
One of my business partners had several stents , in hospital for 2-3 days I think ...close to $100,000
Kiwi
Capt. The issue is how to obtain reimbursement in the remaining big 3 EU markets and spark an increase in script numbers in the existing EU / UK markets .
The current strategy ...same ol same ol ...isnt doing it ( Spain being the possible exception ...but still only 2,000 scripts IIRC )
So what's the boards ( and your ) suggestions for gaining reimbursements and increasing script number in these markets ?
Kiwi
Based on the search results, here are the key things Amarin would need to do to get reimbursement for Vazkepa (icosapent ethyl) in Germany:
Reach a viable agreement with the National Association of Statutory Health Insurance Funds (GKV-SV) on the reimbursement price for Vazkepa:
The search results indicate that after four rounds of negotiations, Amarin and the GKV-SV were unable to reach an agreement on the reimbursement price.
The matter was escalated to the Arbitration Board for a final decision, as the two parties could not come to terms.
Potentially use real-world evidence and data to support the clinical benefits of Vazkepa:
The search results mention that there is a precedent in Germany where a product that received a negative reimbursement decision was able to get it reversed by using real-world evidence and data to demonstrate the clinical benefits.
Amarin indicated they may explore a similar path to resubmit the file in Germany.
The key criticisms of the RESPECT-EPA trial were:
The trial was underpowered and failed to meet its primary endpoint of a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, unstable angina requiring hospitalization, and coronary revascularization. The reduction in this endpoint was of borderline statistical significance (p=0.055).
The trial had a high number of patient withdrawals or protocol deviations, which added uncertainty to the conclusions.
The open-label design, without a placebo control, was a limitation that could have introduced bias.
While the trial showed a signal of benefit consistent with previous trials like JELIS and REDUCE-IT, the magnitude of the potential cardiovascular benefit was uncertain.
There were concerns about the increased risk of atrial fibrillation seen with icosapent ethyl, which could offset any potential cardiovascular benefits.
Some experts, like Dr. Steve Nissen, felt the many limitations of the RESPECT-EPA trial made the results uninterpretable and that it should not be used to support the data from the REDUCE-IT trial.
In summary, the RESPECT-EPA trial was criticized for being underpowered, having design limitations, and failing to provide definitive evidence on the cardiovascular benefits of icosapent ethyl, despite showing a signal of potential benefit.
EPA not EPA+DHA could be beneficial ;however, further investigations are needed
Well your mindsets seem to be to stick with the same ol same ol ...cos eventually ....eventually , the entire Cardiology community will see the light and start aggressively writing scripts ..especially in the EU
Meanwhile ...do the math here, Q1 24 over Q1 23 saw a 41% decrease in US revenues . Similar will happen in Q2 and Q3 and Q4 because the major health providers like Kaiser have switched to generic V or are forcing AMRN to beat generic pricing to retain their market share .
Great deal ..hey we have retained our US market share ...but were losing $ doing it ..but never mind
And while this is going on in the US ...script growth ( except in Spain ) is barely moving .
But lets stick with the same ol same ol ...with a $50m share buy back thrown in so mgt options that vest next April, can maybe cash in .
Cos thats the best idea we ( mgt ) can come up with .
Kiwi
https://eas-congress.com/2024/. Big Cardiology conference in the EU coming up
What's AMRN presenting ...anyone ?
Alright
Beyond LDL-c: Residual risk and Elevated triglycerides - Industry session sponsored by Amarin
Welcome and introduction
Presenter
Michel Farnier (France)
Lecture Time
14:45 - 14:50
Residual risk and Elevated triglycerides: Where do we stand in 2024?
Presenter
Lale S. Tokgözoglu (Turkey)
Lecture Time
14:50 - 15:00
Icosapent Ethyl in clinical practice : Who needs it the most?
Presenter
Azfar Zaman (United Kingdom)
Lecture Time
15:00 - 15:10
Icosapent Ethyl in clinical practice: What mediates the protective effects?
Presenter
Lluis Masana (Spain)
Lecture Time
15:10 - 15:20
Chromosome ..Well I am definitely in the minority .
You may think R-IT is the gold standard but because of the placebo used some major figures in the Cardiology world don't buy it .
Capt has a long list of non believers .
This affects script uptake here and in the EU
The current trajectory for AMRN ....significant decline in US sales , combined with minimal sales in the EU indicates a slow steady decline to oblivion ...not a BP buyout.
So what to do about that ?
Apparently nothing according to most on this board
Kiwi
Jim I was on Mevacor . Back then it was only for the HeFH indication I believe. Approval for primary prevention etc for CAD came years later ...1995 I think .
Above is just from memory .
The big change was Lipitor . I was given free samples that lasted about 6 mths ...handed out like candy on Halloween, when that hit the market .
Did you sell Lipitor ( Atorvasatatin ) also .?
Kiwi
Cosa ...No I had sold all my shares in the $4's thinking there was upside to UNCY ...we''l know if that was a good idea or not probably by the end of this month.
They say roughly half their sale are to Medicare patients ,
But Medicare can't use the coupon so its a Tier 5 drug ( at Kaiser anyway ) where patients typically pay 1/3 rd of the cost ...in this case around $1,000 each month
Co won't disclose how much of their " sales " were no cost to the patient .
Scripts are normally 30 days at a time ( NDS ) with a PA ( prior approval ).
Most hate the existing Pho binders so getting the PA is no problem . Getting renewal month after month at no cost to the patients ...dont know how long that would last or how many of the Medicare patients actually paid the full copay .
ARDX had prepared the launch really well . Had Renal depts identify those most likely to try XPHOZAH all ready in advance and then I suspect dropped a whole lot of free samples for the first month or 3 .
IF the copay for Medicare patients is around $1,000 a month , few of these patients IMHO will stay on X ...or sharply reduce how much they take each day
JMO
Kiwi
Another example of a short CAD trial ...this time in Sweden
The SWITCH-SWEDEHEART trial is a prospective, multicenter, open-label, cross-sectional, stepped-wedge cluster-randomized clinical trial.
The trial aims to systematically evaluate the transition from using ticagrelor to using prasugrel as the preferred P2Y12 inhibitor drug for treating patients with acute coronary syndrome (ACS) in Sweden.
The administrative regions in Sweden will constitute the clusters, and the order in which they switch from ticagrelor to prasugrel will be randomly assigned.
The primary endpoint is the composite 1-year rate of death, stroke, or myocardial infarction.
The trial will establish an important standard for introducing and evaluating the effects of healthcare changes within the Swedish healthcare system.
The trial is designed to provide a systematic, randomized comparison between the use of ticagrelor versus prasugrel for treating patients with ACS in a real-world setting.
Try this with available Kaiser data
PRECLUDE-2 was a Swedish registry study involving over 100,000 post-MI patients. It found that the majority of these patients who have at least two cardiovascular disease risk factors showed a marked but gradual increase in incidence of cardiovascular death, MI or stroke during the follow-up period of three years. If all five cardiovascular risk factors studied were present, there was up to a nine-fold increase in incidence of CV events, compared to when only one risk factor was present.
RMB. As I have posted before . You pick a R-IT subgroup with a high risk reduction where the event lines separated fairly early . The Revasc rates ...especially second revasc rates as an example.
Real life example .
Wife was unable to dialyze one of her patients recently because he was complaining of chest pains . Sent to the ER where they found one of his coronary stents had re occluded ( plaque had reformed possibly as a result of injury to the vessel sustained at time of PCI ) .
Patient was not on Vascepa
So run a short trial ...or at least look at Real World evidence for these patients ....Kaiser must have lots of it by now.
SOC ( standard of care ) vs SOC plus Vascepa ...follow rates of re occlusion following a recent PCI .
Huge cost savings if re occlusion rates fall for those on Vascepa .
No placebo , open to all TG levels
Kiwi
Snd. RWE studies are done all the time to inform regulators and physicians ...I've easily identified several .
Heres one on PCSK9's in Germany
A real-world, single-center study that examined the use of PCSK9 inhibitors (alirocumab and evolocumab) in a large patient cohort (n=635) in Germany. This study was conducted at the lipid clinic of Charité Universitätsmedizin Berlin and assessed the prescribing patterns and treatment outcomes of these novel lipid-lowering therapies in a clinical practice setting.
Here are some examples of real-world evidence studies on existing cardiovascular drugs:
Cardiovascular drugs are an area where real-world evidence (RWE) has been increasingly used to supplement clinical trial data. RWE can provide valuable insights into the real-world safety and effectiveness of these drugs beyond the controlled settings of clinical trials.
One example is a study that used insurance claims data to evaluate the cardiovascular safety of the diabetes drug Tradjenta compared to an older treatment, glimepiride. The study was able to replicate the results of the large CAROLINA randomized controlled trial in a much shorter timeframe of 6 weeks, compared to the 8 years it took to complete the CAROLINA trial. This demonstrates the potential for RWE to efficiently evaluate the safety of cardiovascular drugs.
Another example is a study that used electronic health record data to evaluate the real-world use and outcomes of the heart failure drug Jardiance. The study found that Jardiance was associated with reduced risk of hospitalization and death in a broad population of heart failure patients, including those not enrolled in the original clinical trials. This type of RWE can help expand the understanding of a drug's benefits beyond the narrowly defined patient populations in clinical trials.
RWE has also been used to evaluate the safety of cardiovascular drugs in patient populations excluded from clinical trials. For example, a European health technology assessment agency requested real-world data on the safety of a new oncology therapy in patients with limited cardiac function, who were excluded from the registration trials. The RWE analysis helped inform the coverage decision without the need for an additional clinical trial.
These examples illustrate how RWE can complement clinical trial data to provide a more comprehensive understanding of the real-world use and impact of cardiovascular drugs, ultimately supporting regulatory and clinical decision-making.