I reckon its not that high. The FDA rejects a fair share of drugs with good data but in a case like this, I would think there is a lot of additional factors weighing in its favor. I reckon the real issues will relate to the safety of putting the device in and taking it out, whether additional safety studies are needed to support the approval, whether the plan for Doctor training is adequate and so on.
I do look at it a little differently. At this point, I would say those numbers argue for a 90% chance of success for Probuphine. It's phase III is already positive and the chances of submitting an NDA are 100%. The numbers do emphasize that Probuphine has already jumped the great majority of statistical hurdles to get where it is today.
Good luck to all and I must say I'm a little surprised at the PPS. That being said, there is a big difference in market pricing versus NPV. I am sure Sunil and the leadership will go for the best deal possible, whether that is a partnership with a cash upfront payment, sale of foreign rights with subsequent self-funded U.S. NDA or sale of the company outright. I also wish they were on the NADAQ, but such is life.