1) Re: milnacipran. Forest is expert at being a successful late arrival (Celexa/Lexapro). Fibromyalgia is pretty elusive, no drug has really impressive hit rates, so I expect they will do well with it. Given that I've been predicting approval and own a little CYPB, I'm relieved to have something go right.
2) Saphris. In contrast, Saphris (which failed in a couple of PhIIIs) and Schering-Plough don't impress me. SP must go up against the entrenched antipsychotics, including generic risperdal. I'm going to be looking at the Geodon vs. Saphris comparison (that's the real competition, in the less weight gain, less efficacy cohort) in the next couple of weeks, but I see Pfizer as very difficult for SP to compete with.
3) The Sugammadex rejection was bizarre. But that's today's FDA. One CEO at JOM told me:"You can't even schedule a teleconference, let alone a face-to-face meeting." And they changed the rules on him midstream so they weren't even consistent with their published standards. Almost put him out of business (no, it's not Cortex).
As to the carping about radio silence: I'm still baffled by complaints that Cortex isn't keeping people up to date on the state of negotiations. Just absurd. If someone can give an example of a company which does provide play-by-play, status reports on partnering negotiations, let me know. My stated timeframe was and is January. If we don't hear something by month's end, I'll get nervous--alright, I'm already nervous, then I'll escalate. But one thing I won't do is question whether Cortex management takes this situation and their responsibility to shareholders seriously. That is complete BS.
I will say that I found that press release puzzling. It was an odd hybrid--somehow melding half of a press release intended to publicize sleep apnea with half of one describing RD, and the marriage of the two was really awkward. It's as if their PR firm decided they should put out something to look useful....Cortex management isn't focused on PR at the moment--and if someone says that one of them should be, I would suggest that the search for a partner and/or money is pretty much a fulltime job for all three of them.
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