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Re: antihama post# 2659

Friday, 09/13/2019 12:14:47 PM

Friday, September 13, 2019 12:14:47 PM

Post# of 3283
OMG! Did no one pick up on what JT said at the Morgan Stanley Global HCC 2 days ago??? I finally got to listen to the CC, and my intention was to post a little summary of this CC and of the Rodman & Renshaw CC from the previous day. So here I am almost at the end thinking - just as I thought there was a couple of tidbits of info but nothing too exciting, and then I hear JT say in his routine end of the CC spiel, at minute ~24:20 (it ends at mi 24:48,)

These two lead assets we have, we'll be filing in the 4th Q

What? Now we know Rolontis is going to be filed but pozi too! Mix up? I don't think you can mix up something that specific. Slip up? Probably let the cat out of the bag a little earlier than he wanted to. So, we're now talking approval mid summer assuming a 6 month accelerated timeline. No if, and, or buts about it. Sweet and unexpected! The SVB Leerink quote comes to mind

Thanks to the FDA's speedy cancer drug reviews, kinase inhibitors are making it to market lickety-split, SVB Leerink explains. [my note - yes for pozi] A whopping 77% were evaluated under FDA’s priority review program, and some also nabbed breakthrough therapy designations [my note that's a no for pozi...so far]. All told, the review period for kinase inhibitors has averaged just six months. -post 2648