While this Asenapine delay may turn out to be rather short -- it is also quite possible that FDA will "not like what it sees" ["Cue Salmon, stage left" -- paging Salmon!] in the additional data sets it has requested for Asenapine -- one of Schering's much vaunted "Five Stars" -- now about two years behind the earlier-scheduled US launch date.
This morning's FDA complete response letter comes only one day after the proposed "Over The Counter", or OTC, form of Omeprazole, received an even more unfavorable FDA complete response letter. Wow. That looks like an emerging pattern, here.
More plainly put, it is -- in my experience -- additional evidence that FDA now eyes rather warily every submission from Schering -- given the less than forthcoming nature of the ENHANCE results release-delays, then the attempt to downplay those same results. For what it is worth, Schering is pleased that the letter represents -- it hopes -- only a shortish delay:
. . . .We are pleased with the progress on the Saphris filing and look forward to working with the agency to address its request, finalize the product labeling and gain approval," Thomas Koestler, president of the Schering-Plough Research Institute, said in a statement. . . .
Okay. Right. Check. . . .