Talk about a case of moving goal posts, pushing Labopharm Inc. further away from scoring a touchdown. That's the long and short of it after the drug developer ran into a 300-pound linebacker at the U.S. Food and Drug Administration, which is holding up approval of its once-daily tramadol pain pill. National Bank Financial analyst Prakash Gowd writes that the holdup seems to reflect the FDA wanting a new statistical analysis of the company's latest pivotal trial before it will begin the approval review. But the new analysis was not the one originally requested by the FDA either at the time of Labopharm's regulatory filing or as part of a "special protocol assessment" before the trial began, he suggests. "While this seems unfair to Labopharm and to outside observers, unfortunately it is the FDA's prerogative to change its mind and to adjust its approval requirements, and is part of regulatory risk in drug development." After having Labopharm's target price "under review," Mr. Gowd has settled on $3.75, which would require Labopharm performing another pivotal trial, leading to a two-year delay before approval. The stock is unchanged at $3 on the TSX Friday afternoon.
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