UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Item 8.01 Other Events.
180 Life Sciences Corp. (the “Company”) is providing an update on its previously announced anticipated preliminary discussion (Type C) meeting with the U.S. Food and Drug Administration (FDA) prior to a proposed pre-investigational new drug application (PIND) meeting for its Dupuytren’s disease treatment.
Specifically, the FDA recently provided notice to the Company that the FDA had declined to grant this meeting with the Company regarding its preliminary discussion, Type C meeting for its treatment of early stage Dupuytren’s disease, until more information about the manufacturer of the product is provided.
The Company remains committed to the development of its early stage Dupuytren’s disease treatment and upon advice of its regulatory consultants plans to further correspond with the FDA with the goal of having a Type C meeting with the FDA; provided no assurances can be given that such meeting will be agreed to by the FDA or the timing of such meeting.
This Current Report on Form 8-K, contains forward-looking statements within the federal securities laws, including the safe harbor provisions under The Private Securities Litigation Reform Act of 1995, and, as such, may involve known and unknown risks, uncertainties and assumptions. These forward-looking statements relate to the Company’s current expectations and are subject to limitations and qualifications set forth in the Company’s filings with the Securities and Exchange Commission, including, without limitation, that actual events and/or results may differ materially from those projected in such forward-looking statements. These statements also involve known and unknown risks, which may cause the results of the Company, its divisions and concepts to be materially different than those expressed or implied in such statements. Accordingly, readers should not place undue reliance on any forward-looking statements. Forward-looking statements may include comments as to the Company’s beliefs and expectations as to future financial performance, events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside the Company’s control. More information on potential factors that could affect the Company’s financial results is included from time to time in the “Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s periodic and current filings with the SEC, including the Form 10-Qs and Form 10-Ks, filed with the SEC and available at www.sec.gov. Forward-looking statements speak only as of the date they are made. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: March 28, 2022
180 LIFE SCIENCES CORP. | |||
By: | /s/ James N. Woody, M.D., Ph.D. | ||
Name: | James N. Woody, M.D., Ph.D. | ||
Title: | Chief Executive Officer |