RE:RE:RE:RE:RE:RE:RE:RE:RE:one of the cool things I heard on the call today wasGreat info, Gobbs. Given that PLI started the rolling BLA submission in December and will complete this coming Wednesday, it is likely that FDA will grant the BLA sometime between mid June and early September (the 6 month window). I am confident that PLI will get priority review given that Pg has orphan drug status.
Pierre said that it is likely that the FDA will inspect their facilities in May. This opens the possibility for approval earlier than later (i.e. June/July). The big unknown is whether PLI will get a pediatric voucher at the time the BLA is granted? PLI certainly is in the running for a voucher. If PLI gets it, the Company will have a clear cash runway until big revenues start flowing in 2018 from the commercialisation of Pg and IVIG.
In the interim, I also believe that the Company will deliver on a couple more regional deals. There is also the possibility of a massive partnership on IPF.
The next 6 months are going to be packed full of developments as both the PPPS and SMT platforms start delivering monetary results! I figure the next regional 4050 deal will send the shorts scurrying to the sidelines. It will be nice to have a short squeeze in the lead up to the AGM:-)