RE:Corrected timing of FDA acceptance of Ibalizumab applicationGreat post SPCEO and nice to read on a day when the market is closed in Canada. One small correction to your post would be when the FDA issues priority review and a pdufa date, it will be 6 months from the filing date of the BLA and not the acceptance. Although Mackie and some other analysts are giving early 2018 for approval now I dont think that will be the case unless we are delayed. We should get our PDUFA for early Nov. and then we can easily get an early approval from that date.
If everything goes well we should get BLA acceptance, a PDUFA and priority review sometime in mid June and from what I've read (although not official) once a breakthrough therapy revieves a PDUFA, it is extremely rare for the drug not to be approved on or before that date. Anybody following the Thera story will want to be fully invested when we recieve acceptance in my opionion, institutions and deep pocket investors could be waiting for a PDUFA.