Legal Proceedings.
−Removed: time to time in the future, we may become involved in litigation or other legal proceedings that arise in the ordinary course of business.
−Removed: We are not currently party to any legal proceedings, and we are not aware of any pending or threatened litigation against us that we
−Removed: believe could have a material adverse effect on our business, operating results or financial condition.
−Removed: In the event we are subject to
−Removed: a legal proceeding, it could have a material adverse impact on us because of litigation costs and diversion of management resources.
+Added: From time to time in the future,
+Added: we may become involved in litigation or other legal proceedings that arise in the ordinary course of business.
+Added: Except as disclosed below,
+Added: we are not currently party to any legal proceedings, and we are not aware of any pending or threatened litigation against us that we believe
+Added: could have a material adverse effect on our business, operating results or financial condition.
+Added: In the event we are subject to a legal
+Added: proceeding, it could have a material adverse impact on us because of litigation costs and diversion of management resources.
+Added: SEC Investigation
+Added: On July 19, 2024, the Company
+Added: received a “Wells Notice” from the Staff of the SEC relating to the Company’s previously disclosed SEC investigation.
+Added: The Wells Notice relates to the Company’s disclosures regarding meetings with the United States Food and Drug Administration (the
+Added: “FDA”) regarding the Company’s NDA for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021.
+Added: understands that all conduct relating to the SEC Wells Notice occurred during or prior to fiscal year 2022.
+Added: The Company also understands
+Added: that three of its former officers received Wells Notices from the SEC relating to the same conduct.
+Added: A Wells Notice is neither a formal
+Added: charge of wrongdoing nor a final determination that the recipient has violated any law.
+Added: The Wells Notice informed the Company that the
+Added: SEC Staff has made a preliminary determination to recommend that the SEC file an enforcement action against the Company that would allege
+Added: certain violations of the federal securities laws.
+Added: The Company is continuing to cooperate with the SEC and maintains that its actions
+Added: were appropriate, and intends to pursue the Wells Notice process, including submitting a formal response to the SEC.
Risk Factors.
1 unchanged sentence
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