The prospects for blisibimod don't look much better. Any hope that Anthera would find a partner to help develop blisibimod was dashed when the company raised cash in July to fund the phase III trials. Given the lackluster phase II data, the blisibimod phase III trials are super high risk and won't report any data until 2015.
Charles W. asks, "With respect to
you mentioned it being odd in your article
that the FDA had not replied in the 14 days. Why wouldn't the FDA just have rejected their resubmission? Also, do you think it might have been possible that the FDA requested an additional piece of information without doing a rejection. Does this happen?"
MAP Pharma resubmitted Levadex to FDA 35 days ago. Still no word from the company about whether or not FDA accepted the re-file. The silence is very strange, if not bordering on the absurd.
Under FDA regulations, the agency takes 14 days to notify a company about acceptance of a drug resubmission. The FDA is under no notification time clock if a resubmission is deemed unacceptable. Charles, I'm as baffled by the MAP Pharma situation as you, but it's hard to view the protracted delay as a positive.
-- Reported by Adam Feuerstein in Boston.