CHEK - CITING THE MANY FDA ADVERSE EFFECTS TO KEYSTONE DENTAL - CHECK-CAP FOUNDER STRONGLY RECOMMENDS VOTING AGAINST THE KEYSTONE DENTAL MERGER ALSO RECOMMENDS VOTING FOR THE SYMETRYX BOARD NOMINEES | Benzinga
TORONTO, Dec. 8, 2023 /PRNewswire/ - Further to its news release of November 28, 2023, Symetryx continues to urge its fellow Check-Cap Ltd. ("Check-Cap") (NASDAQ:CHEK) shareholders to VOTE AGAINST the Keystone Dental and FOR the Symetryx slate of highly qualified and independent director nominees. See Symetryx Today Issues Open Letter to Shareholders In Regard to the Upcoming Annual General Meeting (newswire.ca)
Keystone Dental ("Keystone") reported on November 22nd through a 6K filling with the Securities and Exchange Commission (the "SEC") under Check-Cap's SEC filing page, the following: On November 6, 2023, Keystone received a deficiency letter from the U.S. Food and Drug Administration (the "FDA") regarding its Paltop Short Implants in which the FDA requests additional information and raises certain concerns regarding Keystone's submission to the FDA.
While Keystone indicates it intends to proactively engage the FDA on this issue and present information to the agency, there is no guarantee that the FDA will agree with Keystone's determination that a new filing submission was not needed for these products. If the FDA determines that a new filing submission was needed for one or more of the referenced implant bodies, Keystone may be subject to enforcement action and/or it may be required to cease marketing the applicable product and withdraw or recall the subject product from the marketplace until a new submission is made and clearance is obtained (which may not happen in a timely manner or at all), issue corrective communications, or pay fines. This action by the FDA could potentially harm Keystone's business, financial condition ...