Drug-Coated Balloon (DCB) Angioplasty vs. Bare-Metal Stent (BMS) Implantation: A 6-month trial evaluating the clinical outcomes and restenosis rates between DCB angioplasty and BMS implantation in patients with de novo coronary lesions.
Fractional Flow Reserve (FFR)-Guided PCI vs. Angiography-Guided PCI: A 3-month trial assessing the impact of FFR-guided PCI compared to angiography-guided PCI on long-term outcomes such as major adverse cardiac events (MACE) and target vessel revascularization (TVR).
Bioresorbable Vascular Scaffold (BVS) vs. Drug-Eluting Stent (DES): A 1-year trial comparing the safety and efficacy of BVS with DES in patients undergoing percutaneous coronary intervention for stable angina or acute coronary syndrome.

Not to mention, there is always the risk that something goes wrong with the trial.

Re: jessellivermore post# 231436
Wednesday, December 04, 2019 11:45:04 AM
Post# of 423606
JL

I am a sheep farmer scraping a living on the side of the Wicklow hills here in Ireland, your advice and foresight on the darkest days and there have been many, has kept me invested here and for the first time in my life it looks that I can retire financially secure...many thanks.

Market Abuse Regulations: The FCA regulates share buybacks under the Market Abuse Regulation (MAR). MAR sets out rules to prevent market manipulation and insider dealing, which includes rules governing share repurchases. Companies must ensure compliance with these regulations to avoid legal issues.
Disclosure Requirements: Companies engaging in share buybacks must disclose the details of these transactions to the market. This includes the number of shares repurchased, the price paid, and the total value of the buyback. This information helps investors and regulators assess the company's financial health and management's decisions.
Board Approval and Shareholder Communication: Share buybacks typically require approval from the company's board of directors and may also need shareholder approval in certain circumstances. Regulators emphasize the importance of clear communication with shareholders regarding the rationale behind the buyback and its potential impact on the company's financial position.
Market Integrity and Fairness: Regulators are concerned about maintaining market integrity and fairness. They monitor share buybacks to ensure they are not used to manipulate the company's stock price artificially or to mislead investors. Companies must adhere to strict guidelines to prevent such abuses.
Financial Stability and Capital Allocation: Regulators also consider the broader implications of share buybacks on financial stability and capital allocation. Excessive buybacks that jeopardize a company's ability to meet its financial obligations or invest in long-term growth may attract regulatory scrutiny.
Overall, while UK regulators recognize the legitimate use of share buybacks as part of a company's capital management strategy, they enforce rules and guidelines to ensure transparency, fairness, and compliance with market regulations. Companies engaging in share repurchases must navigate these regulatory requirements carefully to avoid legal and reputational risks.
User
What is the difference between UK regulators and US regulators on share buybacks

ChatGPT
The difference between UK regulators and US regulators regarding share buybacks primarily lies in the specific regulations, guidelines, and market dynamics of each jurisdiction. Here are some key differences:

Regulatory Bodies:
UK: In the UK, the Financial Conduct Authority (FCA) oversees share buybacks under the Market Abuse Regulation (MAR) and other relevant guidelines. The London Stock Exchange (LSE) also plays a role in regulating companies listed on its exchange.
US: In the US, share buybacks are regulated by the Securities and Exchange Commission (SEC). The SEC enforces rules and disclosure requirements related to buybacks, including those outlined in Regulation S-K and Regulation M.
Regulatory Framework:
UK: The UK's regulatory framework emphasizes transparency, fair dealing, and preventing market abuse. Companies must comply with disclosure requirements and ensure that buybacks are conducted in a manner that does not manipulate the market or mislead investors.
US: The US regulatory framework for share buybacks also emphasizes transparency and fair dealing. However, there are specific rules governing the timing, pricing, and disclosure of buybacks, such as restrictions on buybacks during certain periods (e.g., blackout periods) and requirements for filing Form 10-Q or 10-K with the SEC.
Legal Environment:
UK: The legal environment in the UK may have different considerations regarding corporate governance, shareholder rights, and fiduciary duties compared to the US. Shareholder activism and engagement are also factors that influence how companies approach buybacks and how regulators view these activities.
US: In the US, shareholder activism and corporate governance practices can impact the way companies conduct share buybacks. Proxy advisory firms and institutional investors often play a significant role in shaping shareholder resolutions and governance policies related to buybacks.
Market Dynamics:
UK: The UK stock market has its unique characteristics, including the presence of the London Stock Exchange and the regulatory landscape specific to the region. Market conditions, investor sentiment, and economic factors influence the frequency and scale of share buybacks in the UK.
US: The US stock market is one of the largest and most liquid in the world, with diverse market participants and regulatory considerations. Buyback activities in the US market can have a significant impact on stock prices, market liquidity, and investor confidence.
Overall, while both UK and US regulators aim to ensure fairness, transparency, and market integrity in share buybacks, the specific regulatory frameworks, legal environments, and market dynamics in each jurisdiction result in differences in how these activities are regulated and perceived. Companies operating in both regions must navigate the relevant regulatory requirements and market expectations when engaging in share buybacks.
User
Are UK regulators concerned about share buybacks for the purpose of inflating low priced shares


Yes, UK regulators are concerned about share buybacks being used for the purpose of inflating low-priced shares. This concern is rooted in the broader objective of preventing market manipulation and maintaining market integrity. Here are some key points regarding this concern:

Market Manipulation: Share buybacks can potentially be used as a tool for market manipulation, especially when they are used to artificially inflate the price of low-priced shares. This can mislead investors and create an inaccurate perception of the company's financial health or market value.
Regulatory Oversight: The Financial Conduct Authority (FCA) in the UK closely monitors share buybacks under the Market Abuse Regulation (MAR) to ensure that they are not used for manipulative purposes. MAR sets out rules and guidelines to prevent market abuse, including activities like price manipulation through share buybacks.
Disclosure Requirements: Companies engaging in share buybacks are required to disclose detailed information about these transactions to the market, including the number of shares repurchased, the price paid, and the total value of the buyback. This transparency helps regulators and investors assess the legitimacy of buyback activities.
Fair Dealing and Investor Protection: UK regulators emphasize fair dealing and investor protection in the context of share buybacks. Companies must conduct buybacks in a manner that does not mislead or harm investors, including avoiding actions that artificially inflate share prices for short-term gains.
Corporate Governance: Share buybacks are subject to scrutiny from a corporate governance perspective as well. Boards of directors and shareholders expect companies to use buybacks responsibly and in the best interests of shareholders and the long-term sustainability of the company.
Overall, while share buybacks are a legitimate financial tool for companies, UK regulators are vigilant about ensuring that they are not used to manipulate markets, inflate share prices artificially, or mislead investors. Companies must adhere to regulatory requirements, transparency standards, and ethical practices when engaging in share buybacks to avoid regulatory scrutiny and maintain market confidence.
User
What are the UK regulators and banks concerns about share buybacks


UK regulators and banks have various concerns about share buybacks, which revolve around financial stability, market integrity, investor protection, and corporate governance. Here are some of the key concerns they may have:

Financial Stability: One of the primary concerns is that excessive share buybacks could impact a company's financial stability. If a company allocates too much capital to buybacks instead of investing in long-term growth, it may weaken its financial position, particularly during economic downturns or when faced with unexpected challenges.
Market Manipulation: Regulators are concerned about the potential for share buybacks to be used for market manipulation. This includes artificially inflating share prices or creating misleading perceptions about a company's financial health or prospects. Such manipulation can harm investors and undermine market integrity.
Liquidity and Capital Adequacy: Banks and regulators also consider the impact of share buybacks on a company's liquidity and capital adequacy. Excessive buybacks can reduce a company's cash reserves and available capital, which may affect its ability to meet financial obligations or pursue strategic initiatives.
Investor Protection: Ensuring that investors are protected and well-informed is a key concern. Regulators require companies to disclose details of share buybacks, including the rationale, timing, pricing, and impact on capital structure. This transparency helps investors make informed decisions and assess the company's financial health.
Corporate Governance: Share buybacks are scrutinized from a corporate governance perspective. Regulators and stakeholders expect boards of directors to act in the best interests of shareholders and the company as a whole. This includes evaluating whether share buybacks are an appropriate use of capital and align with long-term strategic objectives.
Impact on Shareholder Returns: While share buybacks can enhance shareholder returns by reducing the number of shares outstanding, regulators and banks are concerned about the sustainability and effectiveness of buyback programs. They may assess whether buybacks are generating long-term value for shareholders or merely boosting short-term stock prices.
Regulatory Compliance: Companies engaging in share buybacks must comply with regulatory requirements, including those related to market abuse, disclosure, insider trading, and corporate governance. Non-compliance can lead to legal and reputational risks.
Overall, UK regulators and banks aim to strike a balance between allowing companies to use share buybacks as a legitimate capital management tool while ensuring that such activities are conducted responsibly, transparently, and in the best interests of shareholders and the broader financial system.

According to a study published in JAMA Cardiology in 2019, the median cost of PCI was estimated to be around $35,000, while the median cost of CABG was approximately $45,000.

In 2013, after the publication of the updated recommendations, however, the percentage of atorvastatin prescriptions began to grow regularly from 26% until it reached the highest point at 52% (p = 0.000) in 2019

In Germany, the level of evidence required for the reimbursement of new drugs is quite stringent and follows a systematic process. The German Federal Joint Committee (Gemeinsamer Bundesausschuss or G-BA) is responsible for evaluating the benefits and cost-effectiveness of new drugs to determine whether they should be reimbursed by the statutory health insurance system.

The G-BA typically considers evidence from clinical trials, health economic evaluations, patient-reported outcomes, and real-world data. The level of evidence required includes:

Clinical Trials: High-quality, randomized controlled trials (RCTs) are often required to demonstrate the efficacy and safety of a new drug. These trials should follow rigorous methodologies, including appropriate blinding, randomization, and control groups.
Health Economic Evaluations: Cost-effectiveness analyses are crucial to assess whether the new drug provides value for money compared to existing treatments. This involves comparing the costs of the new drug with its benefits in terms of improved health outcomes.
Patient-Reported Outcomes (PROs): The G-BA also considers patient-reported outcomes, which provide insights into how patients perceive the impact of the drug on their quality of life, symptoms, and overall well-being.
Real-World Data (RWD): Evidence from real-world studies, such as observational studies and post-marketing surveillance data, may also be required to evaluate the long-term effectiveness and safety of the drug in routine clinical practice.

Amarin Corporation plc (NASDAQ:AMRN) today announced that the Company received a Decision to Grant from the European Patent Office (EPO) for a new patent covering VAZKEPA® (icosapent ethyl) that will extend VAZKEPA exclusivity eight additional years into 2039

GISSI-Prevenzione trial in the general framework of secondary prevention

Explanation of Responses:
1. On April 18, 2024, following the conclusion of the Issuer's annual general meeting of shareholders for 2024, the Reporting Person was granted an option to purchase 179,795 Ordinary Shares under the Plan and the Policy. The shares subject to this option shall vest and become exercisable over three years, with 33% to vest on the first anniversary of the grant date and the remaining balance vesting in equal quarterly installments over the subsequent two years on the first day of each April, July, October and January.

Do you think Reduce It would even exist today if FDA had not mandated it? What would Amarin have to sell if they didnt?

Everyone makes money off Amarin except the shares holders

RZLT. ..follow up to my Feb 20th pitch
My guess is that they have completed the P 2 DME trial and will publish results in May 2024 .
I'm up over 100% on this position so have sold half (. Ala bulls make $ but pigs get slaughtered ...or something to that effect )
Will hold the remaining 50% thru read out .

Multi-Center, Randomized, Double-Masked, Placebo-Controlled Parallel-Arm Study
o 94 participants enrolled in the US
• Newly diagnosed treatment naïve DME patients
• CST of =320 µm
• BCVA of =78 ETDRS letters (=20/25 on Snellen chart)
o Dosing regimen
• Once daily oral administration for 3 months
• Three active arms (50mg, 200mg, 400mg) compared to placebo
o Study endpoints
• Primary endpoints: safety; change in CST
• Secondary endpoints
• Change in BCVA; change in DRSS; changes in non-study eye
• Repeat dose pharmacokinetics
o Study goals
• Improvement vs placebo in CST, BCVA
• Dose-response
• Binocular (2-eye) composite responses
o Topline data expected Q2 2024

. Critics argue that companies sometimes use buybacks to artificially inflate stock prices or to benefit insiders with stock-based compensation.
Additionally, if buybacks are funded through debt or at the expense of necessary investments in research, development, or infrastructure, they may not always serve the long-term interests of the company or its shareholders.

Looks like they all received 180,000 at .87 Options and 50.000 free shares no wonder they stepped on the PPS IMO up on monday

“We thank our shareholders for their engagement and for taking the time to vote on key matters for the Company,” said Odysseas Kostas, M.D. and Chairman, Amarin’s Board of Directors. “Most notably, we are pleased to have received shareholder approval to execute the planned share repurchase program which puts us one step closer to returning value to all shareholders. We look forward to completing the necessary steps to begin share repurchases as soon as possible.”

-Piper Sandler Initiates Coverage on Unicycive Therapeutics With Overweight Rating, $9 Price Target

-Piper Sandler Initiates Coverage on Unicycive Therapeutics With Overweight Rating, $9 Price Target

The incidence of AEs was not significantly different between lanthanum carbonate and placebo during the maintenance phase.
The compliance of the present patients to the experimental drugs was quite good.
Compared with previous double-blind reports, lanthanum carbonate was better tolerated in the present study.
The present withdrawal rate during the titration and maintenance phases was the lowest, at only 10.8% and 6.2%, respectively (