Biotech Values

[DewDiligence]

Re: SNUS

>>I'm not sure what the 505(j) is, but I'm sure SNUS was not eligible, otherwise they would have applied for it.<<

505(j) is the section of the Hatch-Waxman act that deals with ordinary generics. TOCOSOL Paclitaxel is different enough from regular Paclitaxel that this route to approval isn’t available.

>>Am I right in assuming that the 505(b)(2) will require only one Phase III trials?<<

Yes.

>>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?<<

You got me on that one. A press release appears to be warranted.

>>Would you rate SNUS a "buy" here?<<

I would have to study it more before answering.