NovoCure Ltd 8-K, filed Nov 4, 2022
NovoCure Ltd (NVCR)
8-K
2022-11-04
For: 2022-11-04
View Original
Added on
April 04, 2026
About this 8-K
NovoCure Ltd filed this 8-K on November 4, 2022.
Items reported
- Item 8.01: Other events
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
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Item 8.01 Other Events.
On October 27, 2022, NovoCure Limited (the "Company") reported in its Quarterly Report on Form 10-Q for the period ending September 30, 2022 that as a result of the implementation of the Medical Device Regulation, the Company's notified body (as well as many other notified bodies throughout the European Economic Area ("EEA")) had suffered a significant backlog in issuing CE Certificate renewals that that may have affected the Company's ability to obtain a renewal of a CE Certificate for Optune before the current CE Certificate expired in October 2022. In the event of a gap between expiration of the current CE Certificate and issuance of the renewal, the Company was permitted to continue to sell and market CE marked Optune from current inventories in the EEA and Switzerland under the expired CE Certificate. On November 4, 2022, the CE Certificate was renewed and no disruption of sales of Optune occurred.
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.
NovoCure Limited
(Registrant)
Date: November 4, 2022
By: /s/ Ashley Cordova
Name: Ashley Cordova
Title: Chief Financial Officer