Thanks rstor. I'm not sure what the 505(j) is, but I'm sure SNUS was not eligible, otherwise they would have applied for it.
Am I right in assuming that the 505(b)(2) will require only one Phase III trials?
Dew, from your experience, is it unusual for a company not to put out a press release on such a significant event. Garren makes the point that this is the news that BP was waiting for, and a BP deal will now be accelerated. Why "such" such positive, significant news in the 8-K?