I agree with Khumba, Contrarian did a great job summarizing the safety study. The chance of FDA approval is very high. In Smith's blog, he pointed out that his concern was with the recent history of the FDA, not with any issues with the drug or the clinical study results.
It was a tough week for the entire stock market and SNTS got hit too. Things still look very good for here. It actually looks a little better, because you shouldn't be buying any growth stocks until the economy recovers, so you have limited choices for stocks with strong potential.
I really almost wish the patent suit was behind us. It keeps some investors on the sidelines and it has nothing to do with this stock reaching greatness.
I was a little concerned when Smith mentioned the 6 mg being used for safety, when 9 mg was going for the NDA filing for induction of remission and his uncertainty with this study. I have a lot riding on this, so I had to do deep DD until I found the answers. With Smith mentioning that Budesonide MMX is the future for SNTS, I think he may have found the conclusion I came to, with some effort. Instead he just threw a doubtful one line statement out there like a piece of red meat to feed to the doubt dogs. The exceptional Phase 3 results for the 9 mg dose with all of that data, is the key to approval. Also, with the pre-NDA filing decision going as planned (as you mentioned, nowheretog), I am confident in holding my position for long term.
Although Smith factors Budesonide MMX sales into his potential scenarios, he mentioned the patent life on the marketed products and uncertainty on the status of Budesonide MMX, as reasons to stand aside for issuing a recommendation on SNTS.
I am of the opinion, SNTS is cheap considering all of the risks out there and potential reward over time for the pipeline. As things become more known about SNTS, we will reap nice rewards as earlier shareholders by sticking to our own opinions based on solid research, having acted before the crowd arrives. JMO
Potential catalysts for roughly the next year (good or bad), are: upcoming sales / earnings announcements, Zegrid outcome, NDA filing for Budesonide MMX, Rhucin Phase 3 trial results, and PDUFA for Budesonide MMX.