−Removed: In addition, on September 2, 2020,
−Removed: a putative class action lawsuit, Chapman v.
−Removed: Fennec Pharmaceuticals Inc., was filed against the Company, Rostislav Raykov and Robert
−Removed: Andrade, in the United States District Court for the Middle District of North Carolina.
−Removed: The complaint alleges that prior to the
−Removed: receipt of the Complete Response Letter from the FDA, Fennec made materially false and misleading statements or omissions and
−Removed: failed to disclose material adverse facts about Fennec’s business operations and prospects.
−Removed: The Company believes that the
−Removed: suit is without merit and intends to defend itself vigorously.
−Removed: Defendants are not required to respond to the lawsuit until the
−Removed: court appoints a lead plaintiff and a post-appointment complaint is filed or designated.
−Removed: The Company has not recorded a liability
−Removed: as of September 30, 2020 because a potential loss is not probable or reasonably estimable given the preliminary nature of
+Added: Legal Proceedings.
+Added: On September 2, 2020, a putative class action
+Added: lawsuit, Chapman v.
+Added: Fennec Pharmaceuticals Inc., was filed against us, our Chief Executive Officer, Rostislav Raykov, and our Chief Financial
+Added: Officer, Robert Andrade, in the United States District Court for the Middle District of North Carolina.
+Added: The complaint alleged that prior
+Added: to our August 10, 2020 receipt of a CRL from the FDA concerning our NDA for PEDMARK TM , we made materially false or misleading
+Added: statements and failed to disclose material facts about the status of our PEDMARK TM manufacturing facility, its compliance with
+Added: current good manufacturing practices, and the impact its status and compliance would have on regulatory approval for PEDMARK TM
+Added: On December 3, 2020, the court appointed a lead plaintiff to represent the putative class.
+Added: On February 1, 2021, the lead plaintiff
+Added: filed an amended complaint.
+Added: The amended complaint added members of our board of directors as defendants, asserts a putative class period
+Added: from December 10, 2018 through August 10, 2020, makes allegations similar to those in the original complaint, and claims the
+Added: defendants violated Section 10(b) of the Securities Exchange Act of 1934.
+Added: On March 3, 2021, defendants filed a motion to dismiss
+Added: the amended complaint.
+Added: On April 2, 2021, plaintiffs filed an opposition to the motion.
+Added: On April 16, 2021, defendants filed a reply brief
+Added: in support of the motion.
+Added: The court has not scheduled argument or issued an order on the motion.
+Added: We believe that the suit is without merit and
+Added: intend to defend it vigorously.
+Added: We cannot predict the outcome of this suit.
+Added: Failure by us to obtain a favorable resolution of the suit
+Added: could have a material adverse effect on our business, results of operations and financial condition.
+Added: We have not recorded a liability
+Added: as of March 31, 2021, because we believe a potential loss is not probable or reasonably estimable given the preliminary nature of
the proceedings.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.