In the last week of June, Cephalon filed a formal response to the FDA's non-approval. The FDA "classified the response as a class two resubmission requiring a six-month review with a PDUFA date of December 30," Baldino said in a July 27, Earnings Call.
Also, in June 2010, the results for a study of Nuvigil, in conjunction with antipsychotics, for schizophrenia showed the drug failed to meet its primary endpoint, and in the July 27, Earnings Call, Dr Lesley Russell, Cephalon's Chief Medical Officer, said the company had "decided not to move forward with cancer related to fatigue for NUVIGIL."
Hammered Again in Court
On the same day that the FDA refused approval of Nuvigil for jet lag, a federal judge refused to dismiss the antitrust lawsuits filed against Cephalon by the Federal Trade Commission and others.