You are right that when the FDA first delivered their complete response letter Remi Barbier, our beloved CEO, claimed that all that was required was 6 months stability data - the packaged product would need to sit on the shelf for 6 months and then be re-examined to confirm that it hadn't deteriorated. It all sounded so straightforward. So if that was the only issue one might reasonably have expected the NDA to have been re-submitted by now.

The terms economical with the truth come to mind. PTIE/King have subsequently stated that as they have to do other tests in connection with the re-submission they might as well throw in a likeability study - not required for approval but might as well include it. A likeability study will take at least a year to conduct. So that still doesn't explain why Remoxy's NDA won't be re-submitted until H2 2010. Some have suggested that certain changes have been made to the formulation - unlikely in my opinion as surely the FDA would have required further clinical studies if that was the case. Well in reality nobody knows what the problem is because nobody has told us. Its so top secret that we have to be kept in the dark. 11 months after the issue of the CRL we are none the wiser. Its a strange old world.