Shares of drug development firm Nuvo Research (TSX: T.NRI, Stock Forum), climbed 15.4% to 15 cents Wednesday after the company announced that it has successfully completed all of the studies to support the resubmission of its Pennsaid application to the United States Food and Drug Administration.
Pennsaid is currently marketed in Canada and several European countries to treat the pain and symptoms associated with osteoarthritis.
"We are confident that the results and information gathered from these studies will provide the FDA with the data it requires to give Nuvo final, unconditional approval to market Pennsaid in the U.S." said Henrich Guntermann, president and CEO of Nuvo.
The company says it is in the process of finalizing its resubmission for Pennsaid approval, which it expects to file with the FDA within the next 60 days.
“Nuvo's resubmission is a complete response amendment to an approvable letter for Pennsaid received from the FDA in December of 2006. In that letter, the FDA confirmed that Pennsaid could be approved for sale in the U.S. once certain conditions were satisfied. None of the conditions relate to clinical efficacy or clinical safety of Pennsaid, which were evidenced in Nuvo's Phase 3 clinical trials, and the FDA has not requested that Nuvo conduct any additional clinical efficacy or safety trials,” says the company.
Wednesday morning on the company’s Bullboard, Kwikwi said: “completion of all studies. Excellent news!!!!!!!!!!! Better late than never. Us longs will finally see the sunshine on their parade[sic].”
