On Wednesday a case was filed in the Middle District of North Carolina by investor Jim Chapman as a class action against Fennec Pharmaceuticals Inc., Rostislav Raykov, and Robert Andrade. The plaintiff alleges that the defendants made false statements in their required Securities and Exchange Commission (SEC) filings.
The complaint recounted that on February 11, 2020, Fennec announced that it had completed its submission of a New Drug Application for the drug Pedmark, a sodium thiosulfate anhydrous injection, for the prevention of platinum-induced ototoxicity in pediatric cancer patients.
The plaintiff contends that the announcement and later updates to this announcement were materially misleading or false because they failed to disclose that the manufacturing facilities producing the drug did not comply with current good manufacturing practices. The plaintiff argued that as a result of this failure in practice, the approval was reasonably likely to be delayed by the Food and Drug Administration and the defendants’ positive statements as to the prospects of approval were materially misleading and lacked reasonable basis.
The plaintiff is suing for compensatory judgment regarding the misleading statement including damages an interest. They are represented by Blue LLP, Glancy Prongay & Murray LLP, and the Law Offices of Frank R Cruz.