Givens said the FDA "would be within its rights" to restart the clock, but refused to speculate on whether or not they would do so. He said that he learned of the letter last night and had not had the chance to speak to the people who would be doing the reformatting. As such, he did not know if it would be a few days or a few hours, but strongly suggested that early next week at the latest, they'd be able to resubmit. He emphasized that they got communications from the FDA of this sort during the review process, but usually by email. I gather that since the FDA for some reason chose do put this formatting request into an official letter, ENCY is obligated to go public with it. My impression is that it is not anything of the magnitude of NBIX' early screwup of their electronic submission for Indiplon.
As stated in the PR, ENCY will ask for expeditious review because it's basically one item, one table. Whether or ot the FDA goes that way or not is anyone's guess. It's the holidays, after all. Shouldn't slow ENCY down more than a month, in any case, and I still think they'll beat MYOG/GILD to market. Though not by as much as I hoped, perhaps.
That's the overriding concern here -- aside from Ambrisentan POSSIBLY being the slightly better drug (but to a clinically relevant extent? I personally doubt it) -- and with the A NDA getting ever closer, analysts were punchy -- one was even combative -- on this call. Everyone seems to be assuming that the Ambrisentan NDA will fly right through. I wouldn't bet on that, either.
I didn't get filled on my attempt to add cheap this morning, but I am still going to try.
Cheers, Tuck |
