Safety issues. NOt effectiveness. Didn't you read the press release?
The assumption by DRRX was that the SAFETY has been proven over and over again on the basic drug. THE FDA was not clear enough in their initial allowance of the trials. DRRX met the END POIIMTS so the FDA comes up with a new wrinkle, just like they did with REMOXY . We all get screwed but it should be a period of time until the SAFETY ISSUE is again proven to the FDA for the umptyumpth time.