Re: WHAT??? 4430 IV trial was already completed!!!
Weird - you would think a straight answer would be easy enough. Here is link for a comparison of updates - it lists Marburg as the disease being tested. There is also one on the trials site listing Sao Paolo for the yellow fever testing.
Since no 7353 NDA PR, I think they might have got some sort of CRL for additional info. That would be nuts considering the fast track process should have been very iterative and transparent about what the NDA should contain...but I do see other CRL PR's from other firms that say they were totally surprised when issued a CRL with items never mentioned during fast track. So we shall see what happens after 72 days.