How likely is FDA etc. approval of Zomaril? Hard to say, someone else can try to put a probability number on it, still a lot of risk of non-approval; and since this is probably a one-product company, FDA non-approval would be nasty for TTP's stock price.
But IMO the risk of non-approval appears to have gone down recently. Novartis presented a lot of information on Zomaril at its R&D conference in NYC on 9/21. Indeed, Novartis unexpectedly summarized results from the first 600 patients in the Phase III (previously we had results of only a 90-patient Phase II), and spent more time and presented more slides on Zomaril than on any other pipeline drug. In short, Novartis appears to be very enthusiastic about the drug.
Here is the link to the R&D conference info: info.novartis.com Slides 30-36 are on Zomaril/iloperidone.
Here is a link to the individual slides: info.novartis.com
There were a number of posts on the Yahoo TTP board about the R&D conference, one by someone in attendance, others by those who listened to an internet audio feed, and some comments on the data. See posts in range 1062-1090, especially 1077, 1079, 1081 (http://messages.yahoo.com/bbs?action=m&board=7077329&tid=ttnp&sid=7077329&mid=1081 ), and 1090. (On Yahoo, you can get a list of 41 posts, 10 before and 30 after any given post, by clicking on "Msg. List" below that post. For example, if you go to post 1074 messages.yahoo.com and click on "Msg List" you will get a list of posts 1064 through 1104, covering the conference posts.)
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