OPKO Health, Inc. (NASDAQ:OPK) Files An 8-K Regulation FD Disclosure
On July 29, 2019, OPKO Health, Inc. (the “Company”) and Phillip Frost, M.D., Chairman and Chief Executive Officer released a joint statement on the Company’s website regarding Dr. Frost’s recent hospitalization. According to the statement:
Dr. Frost informed the Company that he admitted himself into the hospital within the last few days after experiencing chest pains. Dr. Frost has undergone a successful surgery, and he is expected to make a full recovery. Dr. Frost has been in regular contact with Company management and members of the Board of Directors during his hospitalization, and the Company is continuing to operate normally. The Company will provide further details as appropriate. In the meantime, the OPKO family wishes Dr. Frost a speedy recovery.
As previously announced on June 20, 2019, the Company submitted a de novo request to the U.S. Food and Drug Administration (“FDA”) seeking regulatory clearance for the 4Kscore® test. The Company plans to refile its 4Kscore® test submission as a premarket approval (“PMA”) application. A PMA submission is the review process used by the FDA to evaluate the approvability of Class III medical devices. The decision to submit the 4Kscore® test as a PMA submission is based on FDA feedback to the Company’s de novo request for this test, which has now been withdrawn. The FDA did not request any additional clinical data or any additional clinical trials in connection with a PMA submission. The Company currently anticipates submitting the PMA application in August 2019.
Forward Looking Statements
This Form 8-K contains “forward-looking statements” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning, including statements regarding Dr. Frost’s recovery and the PMA submission, as well as other non-historical statements about our expectations, beliefs or intentions. The forward-looking statements contained in this Form 8-K speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
About OPKO Health, Inc. (NASDAQ:OPK)
OPKO Health, Inc. (OPKO) is a healthcare company. The Company operates through two segments: diagnostics and pharmaceutical. The pharmaceutical segment consists of its pharmaceutical operations in Chile, Mexico, Ireland, Israel and Spain, and its pharmaceutical research and development operations. The diagnostics segment primarily consists of its clinical laboratory operations. The Company’s diagnostics business includes Bio-Reference Laboratories (Bio-Reference), which is a clinical laboratory with a genetic testing business, including the 4Kscore prostate cancer test and the Claros 1 in-office immunoassay platform. Its pharmaceutical business includes OPKO Biologics, which features hGH-CTP, a once-weekly human growth hormone injection (in Phase III and partnered with Pfizer), and a longer acting Factor VIIa drug for hemophilia (Phase IIa). In addition to its pharmaceutical and diagnostic development programs, it owns pharmaceutical platforms in Ireland, Chile, Spain and Mexico.
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