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ACRO Offers Unique Insights on Risk-Based Monitoring of Clinical Trials, and Calls for Adoption of RBM as a Best Practice

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WASHINGTON–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/clinicalresearch?src=hash” target=”_blank”gt;#clinicalresearchlt;/agt;–Following meetings with then-Commissioner Scott Gottlieb and senior
leadership from the Center
for Drug Evaluation and Research
on the role of CROs and technology
companies in designing and implementing risk-based monitoring (RBM) of
clinical trials, the Association
of Clinical Research Organizations (ACRO)
 this week submitted
extensive comments on recent FDA Guidance.

Increasing the use of innovative RBM technologies helps make clinical
trials safer, more efficient and higher quality. ACRO’s comments offer
unique insights into the recent expansion of RBM implementation and call
for further increasing the use of these oversight technologies.

Having surveyed its member companies, ACRO is pleased to report that
adoption of RBM tools is growing rapidly. In 2016, less than 20 percent
of new trial starts employed some form of RBM oversight. In 2018, a
majority of new trial starts were using RBM. Challenges to
implementation of RBM remain, including perceptions that traditional
oversight methods are lower risk and less subject to critical scrutiny
by U.S. and E.U. regulators.

ACRO’s comments note that the FDA could help increase RBM implementation
by articulating stronger and more straightforward support for risk-based
monitoring approaches, specifically describing RBM as a “best practice.”

In its comments, ACRO was pleased to include a graphic describing The
Risk-Based Monitoring Landscape
since 2016. “We look forward to
continuing to provide the FDA with unique insights from our member
companies,” said ACRO Executive Director, Doug Peddicord. “ACRO members
are innovators in the development of RBM technologies. We are pleased to
work with sponsors, research sites and the FDA to help ensure the safety
of trial participants and the quality of the data submitted for new
product approvals.”

About ACRO

The Association of Clinical Research Organizations (ACRO) represents
companies that provide a variety of specialized services that support
the development of new pharmaceuticals, biologics and medical devices.
Through its member companies, ACRO helps improve the quality, efficiency
and safety of biomedical research. ACRO member companies employ more
than 130,000 professionals worldwide and conduct or support the vast
majority of clinical trials.

Contacts

Matt Feldman
[email protected]


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Cannabis

Cannabis Concentrate Market to Cross US$2.4 Billion by 2030 amid Rising Medical and Recreational Demand

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transfer

IMC to transfer its Oranim Pharmacy shares back to the seller

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imc-to-transfer-its-oranim-pharmacy-shares-back-to-the-seller

TORONTO and GLIL YAM, Israel, April 16, 2024 /PRNewswire/ — IM Cannabis Corp. (CSE: IMCC) (NASDAQ: IMCC) (the “Company” or “IMC“), a leading medical cannabis company with operations in Israel and Germany, is announcing that, further to the news release dated January 12, 2024, the Company has decided not to make remaining installment payments installments (i.e. NIS 5,873K including interest or 2,154K CAD) by IMC Holdings Ltd., and as such will transfer the 51% shares held by IMC Holdings Ltd back to the  seller.

“With the April 1st cannabis legalization in Germany, we are focusing our resources on the German market, where we expect to see the biggest growth potential,” said Oren Shuster, CEO of IMC. “With both of our core markets, Germany and Israel, currently undergoing rapid evolution, we need to assure that we allocate our resources to the growth opportunities where we expect the best return on investment.”

About IM Cannabis Corp.

IMC (Nasdaq: IMCC) (CSE: IMCC) is an international cannabis company that provides premium cannabis products to medical patients in Israel and Germany, two of the largest medical cannabis markets. The Company has recently exited operations in Canada to pivot its focus and resources to achieve sustainable and profitable growth in its highest value markets, Israel and Germany. The Company leverages a transnational ecosystem powered by a unique data-driven approach and a globally sourced product supply chain. With an unwavering commitment to responsible growth and compliance with the strictest regulatory environments, the Company strives to amplify its commercial and brand power to become a global high-quality cannabis player.

The IMC ecosystem operates in Israel through its commercial relationship with Focus Medical Herbs Ltd., which imports and distributes cannabis to medical patients, leveraging years of proprietary data and patient insights. The Company also operates medical cannabis retail pharmacies, online platforms, distribution centers, and logistical hubs in Israel that enable the safe delivery and quality control of IMC’s products throughout the entire value chain. In Germany, the IMC ecosystem operates through Adjupharm GmbH, where it distributes cannabis to pharmacies for medical cannabis patients. Until recently, the Company also actively operated in Canada through Trichome Financial Corp and its wholly owned subsidiaries, where it cultivated, processed, packaged, and sold premium and ultra-premium cannabis at its own facilities under the WAGNERS and Highland Grow brands for the adult-use market in Canada. The Company has exited operations in Canada and considers these operations discontinued.

Disclaimer for Forward-Looking Statements

This press release contains forward-looking information or forward-looking statements under applicable Canadian and U.S. securities laws (collectively, “forward-looking statements”). All information that addresses activities or developments that we expect to occur in the future are forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek”, “anticipate”, “believe”, “plan”, “estimate”, “expect”, “likely” and “intend” and statements that an event or result “may”, “will”, “should”, “could” or “might” occur or be achieved and other similar expressions. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to,  the occurrence of growth opportunities and the likelihood of growth potential.

Forward-looking statements are based on assumptions that may prove to be incorrect, including but not limited to: the development and introduction of new products; continuing demand for medical and adult-use recreational cannabis in the markets in which the Company operates; the Company’s ability to reach patients through both e-commerce and brick and mortar retail operations; the Company’s ability to maintain and renew or obtain required licenses; the effectiveness of its products for medical cannabis patients and recreational consumers; and the Company’s ability to market its brands and services successfully to its anticipated customers and medical cannabis patients.

The above lists of forward-looking statements and assumptions are not exhaustive. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated or implied by such forward looking statements due to a number of factors and risks. These include: any failure of the Company to maintain “de facto” control over Focus Medical in accordance with IFRS 10; the failure of the Company to comply with applicable regulatory requirements in a highly regulated industry; unexpected changes in governmental policies and regulations in the jurisdictions in which the Company operates; the effect of the reform on the Company; the Company’s ability to continue to meet the listing requirements of the Canadian Securities Exchange and the NASDAQ Capital Market; any unexpected failure to maintain in good standing or renew its licenses; the ability of the Company and Focus Medical (collectively, the “Group”) to deliver on their sales commitments or growth objectives; the reliance of the Group on third-party supply agreements to provide sufficient quantities of medical cannabis to fulfil the Group’s obligations; the Group’s possible exposure to liability, the perceived level of risk related thereto, and the anticipated results of any litigation or other similar disputes or legal proceedings involving the Group; the impact of increasing competition; any lack of merger and acquisition opportunities; adverse market conditions; the inherent uncertainty of production quantities, qualities and cost estimates and the potential for unexpected costs and expenses; risks of product liability and other safety-related liability from the usage of the Group’s cannabis products; supply chain constraints; reliance on key personnel; the risk of defaulting on existing debt and war, conflict and civil unrest in Eastern Europe and the Middle East

Any forward-looking statement included in this press release is made as of the date of this press release and is based on the beliefs, estimates, expectations and opinions of management on the date such forward-looking information is made.

The Company does not undertake any obligation to update forward-looking statements except as required by applicable securities laws. Investors should not place undue reliance on forward-looking statements. Forward-looking statements contained in this press release are expressly qualified by this cautionary statement.

Company Contacts:

Anna Taranko, Director Investor & Public Relations
IM Cannabis Corp.
+49 157 80554338
[email protected]

Oren Shuster, Chief Executive Officer
IM Cannabis Corp.
[email protected]

Logo – https://mma.prnewswire.com/media/1742228/IM_Cannabis_Logo.jpg

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Cannabis

Right on Brands Announces Major Product Line Expansion via HONEY® Brands

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GrassNews.net: Your premier portal for the latest developments in the cannabis industry. We provide timely news, insightful analysis, and in-depth features on everything from legislation changes and business trends, to scientific research and lifestyle topics. Stay informed and navigate the rapidly evolving cannabis landscape with GrassNews.net..

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