FDA Guidance on the Distribution fo Reprints
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The FDA issued guidance on the distribution of publications regarding off-label uses of medical devices. The guidance outlines criteria for reprints and articles to be distributed, including that they be peer-reviewed and published in accordance with scientific principles. Reprints must address adequate clinical investigations and not be misleading. They must be distributed without edits or influence from device companies and include disclosure statements. Examples not consistent with the guidance are letters to editors and abstracts with little substantive discussion. The FDA does not intend to take enforcement action if information is distributed according to the recommendations.
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Robert J. Dickson submitted comments to the U.S. Department of Commerce's Bureau of Industry and Security's Titanium Sponge Working Group. He has over 20 years of experience in the titanium industry as the CFO of Dynamet Incorporated. In his comments, he recommends that the working group comprehensively review financial and regulatory filings of major titanium companies, make efforts to incentivize and support titanium processing in the U.S., retain intellectual developments in the U.S., support growth of the U.S. employment base, use tariffs when necessary, consider stockpiling titanium ingots, establish relations with non-U.S. titanium producers, and plan for reliance on foreign supply chains in
Dickson's Poems
This poem celebrates the new Covid-19 vaccine and hopes that it will allow life to return to normal. It expresses excitement that the suffering, fear, isolation, and risk of infection and death from the virus may soon end now that the vaccine is available. It hopes people will stop wearing masks and be able to hug friends again as the pandemic nightmare comes to an end. The poem encourages building a better life as the vaccine brings an end to the fear and strife of the past year.
Now is the time to evaluate solar and wind generated power
The document discusses the benefits of solar panels and wind turbines for businesses. It notes that political changes and concerns over climate change may result in new legislation that provides subsidies and reduces costs for renewable energy projects. The document recommends that CEOs, COOs, and CFOs evaluate utilizing solar panels or wind turbines at their facilities, as now is a good time to begin planning such projects. It outlines factors to consider in deciding if solar or wind projects are suitable, as well as providing example plans for executing a renewable energy project.
Titanium Sponge
Titanium sponge is a porous form of titanium produced in the first stage of processing titanium ore into alloys. Titanium alloys are used across many industries like aerospace, medical, and sports equipment due to their strength and corrosion resistance. The United States imports over 60% of its titanium sponge needs and only has one facility capable of processing titanium ore into sponge, making stockpiling difficult since sponge degrades over time.
SPAC Attack: SEC 12/22/2020 Disclosure Guidelines
This document discusses the process of taking a company public through a special purpose acquisition company (SPAC). It outlines the key steps and roles of the SPAC sponsors in launching the initial public offering, identifying an acquisition target, and completing the business combination to bring the target public. The document also provides an overview of the services offered by Dickson Consulting to support companies throughout the SPAC process.
Letter to SEC on Finders
The document provides a response to the SEC's proposal to grant an exemption allowing natural persons called "Finders" to connect investors with small businesses needing capital without registering as brokers. The response recommends: (1) eliminating the two proposed tiers of Finders and having one tier with comprehensive regulations; (2) expanding the definition of Finders to include professional service providers; and (3) requiring Finders to register online with the SEC and confirm understanding and intent to comply with regulations. The response then answers each of the SEC's 45 questions, providing further recommendations to improve the proposed exemption.
CMS Proposal--Valley of Death
This document is a letter submitted in response to a proposed rule from the Centers for Medicare & Medicaid Services regarding Medicare coverage of innovative medical devices designated as breakthrough by the FDA. The letter applauds the proposed rule, which would provide national Medicare coverage starting on the date of FDA market authorization for 4 years. This would help start-up medical device companies commercialize their products after FDA approval and avoid the "Valley of Death" period between approval and reimbursement when patients may go untreated and companies may fail financially. The letter urges CMS to finalize and implement the proposed rule, arguing it would benefit both patients and the medical device industry. It is signed by current and former executives, investors, and advisors in start-up medical
Fitting the Pieces Together
McCracken Alliance Partners (MAP) is a partnership of experienced CFOs and finance executives that provides a range of financial leadership services to companies. This includes interim or full-time CFOs, board membership, mergers and acquisitions advisory roles, and special projects. Founder Bob Dickson is a partner at MAP and Dickson Consulting. The presentation summarizes MAP's services and partnerships with other professional services firms that help support clients' needs. It also discusses how the COVID-19 pandemic has changed work environments and increased the ability to provide services virtually from anywhere.
Role of the Chief Financial Officer
The document discusses the challenges facing chief financial officers in closing the 2020 financial year due to the COVID-19 pandemic. It notes that staff may be working remotely, disruptions occurred, and systems/controls changed. Business conditions also changed as supply chains were disrupted and strategies changed. As a result, the CFO faces more issues than ever in the 2020 financial closing. The presentation then outlines the role of the CFO and some potential issues they may face in the closing.
Creating a M&A Advisory Board
Creating a M&A advisory board can help companies achieve their objectives of acquiring other companies or selling their own company. M&A transactions are complex, risky, and expensive, so having independent advisors with M&A expertise can increase the likelihood of success. A M&A advisory board can provide advice and expertise to assist the board of directors and management in their strategic objectives. Setting up an effective M&A advisory board requires defining its mandate, selecting qualified members, and managing the board to maximize its contributions.
Now is the Time for CEO's, COO's and CFO's to Evaluate the Use of Solar Panels
- Bob Dickson, founder of Dickson Consulting and partner at McCracken Alliance Partners, is presenting on evaluating the use of solar panels for CEOs, COOs, and CFOs.
- Political changes under the Biden administration may result in increased funding for clean energy projects like solar, making them more economically feasible. Additionally, reducing or eliminating tariffs on solar imports could lower costs.
- Now is the time for companies to establish cross-functional teams to evaluate installing solar panels, considering factors like available roof space, energy consumption needs, and geographic suitability. Advisory boards including financial experts can help develop and oversee solar projects.
Professional Services to Support VC and PE Activity
MAP provides professional services to support venture capital and private equity firms, including serving on advisory boards, managing the office of the CFO, addressing capital formation issues, and supporting M&A transactions. Bob Dickson is a partner at MAP who has experience as CFO of companies that were sold, such as CardiacAssist which was sold for $250 million. MAP works with a network of CFO advisors across the US to provide local and national services and links clients to technical expertise.
Audit Committee:Financial Leadership From The Top
The document discusses the role and responsibilities of an audit committee. It provides an overview of how an audit committee should provide oversight of an organization's financial reporting and internal controls. This includes coordinating with leadership, developing an audit committee charter, overseeing external financial reporting and the external audit, monitoring internal controls and risk management, and reporting to the full board of directors. The document also describes services that McCracken Alliance Partners (MAP) can provide to assist audit committees, such as performing reviews, providing temporary audit committee members, and advising audit committees.
Professional Services to Support M&A Activity
Dickson Consulting provides professional services to support merger and acquisition activity. Founder Bob Dickson has over 40 years of experience as a CFO for both smaller and publicly traded companies. Dickson Consulting's services include serving on an M&A advisory board, managing the office of the CFO, addressing capital formation issues, supporting transaction execution, providing investment banking for exits, searching for acquisition candidates, and providing HR and risk management advisory services. The document discusses these services and provides examples of Dickson Consulting's experience. It also provides information on working with a community of professional partners including legal counsel, investment bankers, and firms that specialize in acquisition searches.
Entrepreneur at the Controls
This document discusses financial statements and how they relate to entrepreneurial businesses. It provides definitions for key financial terms like assets, liabilities, equity, income statement, balance sheet, and cash flow statement. It explains the purpose and components of various financial statements. The document also discusses financial analysis metrics for evaluating a company's profitability, solvency, and efficiency.
401k Education
This document provides an overview of a 401(k) plan education presentation by Dickson Consulting. It includes sections on investor considerations, background on 401(k) plans, investing overview, types of mutual funds, and additional information. The presentation covers topics like risk tolerance assessments, asset allocation strategies, and guidelines for conservative to aggressive investment approaches. It aims to promote understanding of 401(k) plans and the investing process without providing specific investment advice.
Financial Reporting for Entrepreneurs
The document provides an overview of financial reporting for entrepreneurs. It discusses key financial statements including the balance sheet, income statement, and statement of cash flows. It aims to help entrepreneurs better understand and explain financial statements to demonstrate the growth and strength of their business to various stakeholders. The presentation covers accounting principles, forms of business organizations, and components of the major financial statements.
Financial Tips for Survival
This document provides tips for entrepreneurial companies during an economic slowdown. It recommends preparing detailed short-term forecasts, strengthening the balance sheet by improving financial ratios and having more cash, cutting costs and reducing burn rates, focusing on revenue generation and variable costs, shifting to equity-based compensation, slowing down payables and accelerating receivables, turning inventories, and exploring funding alternatives. Maintaining strong financial management is key to weathering an economic downturn.
Physician Payment Sunshine Act
Letter to new CMS Administrator suggesting that Physician Payment Sunshine Act should be terminated immediately
Response to FDA on Off-Label Use
Comment letter responding to FDA's request for comments on "off-Label" issues.
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Letter of comment to DOC Titanium Sponge Working Group
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