Leighton H. writes, "Wow! You have been silent in regard to Cell Therapeutics (CTIC) lately. No comment about the confirmation of the significance of the PIX301 trial by the independent radiological review, or the upcoming EMA decision on pixantrone, or the reconsideration of the FDA decision in regard to pixantrone. Last I heard from you were comments to your blog some months ago where, when asked about your thoughts on the chances of approval of pixantrone by the FDA, you stated '0% chance.' Do you still hold the same opinion?" I do, although I believe the question to me dealt with Cell Therapeutics' chance of winning pixantrone approval based on the appeal of the FDA's 2010 rejection. This is what I wrote about the pixantrone appeal last December: "The FDA appeal is a desperate Hail Mary that is highly unlikely to succeed. I also fail to see a scenario by which European regulators reach a more positive conclusion about pixantrone compared to their U.S. counterparts at FDA." I don't see any reason to amend that prediction, a year later.
@yemoko asks, "Is the dream over for Fanapt? What do you make of their new hire?" I have a hunch Novartis ( NVS) is getting ready to give up on the schizophrenia drug Fanapt due to rock-bottom sales, leaving partner Vanda Pharmaceuticals ( VNDA) with a major headache. I'm just speculating, admittedly, but hear me out. On Monday, Vanda announced the hiring of a chief commercial officer. On Tuesday, Novartis announced third-quarter financial results, which quite conspicuously excluded any mention of Fanapt sales. Vanda owns Fanapt but licensed U.S. marketing rights to Novartis in exchange for royalties on sales. Vanda sells no drugs on its own and isn't close to being in a position to sell drugs, so why is the company hiring a chief commercial officer? Unless Vanda knows that Novartis is about to abandon Fanapt at its doorstep.