There are a number of things DNDN is doing that I don't think are really great including the way their PR presents their limited scientific results ( see comments earlier on my conjecture regarding Small's attitude related to this ).
However, I have to reserve judgement on the specific suit until I read a (free) copy of the complaint.
Concerns about the ability to find convincing efficacy data from the interim look relate to the whole TTP and dynamics/trajectory issue yet again. I'm not claiming DNDN should have invested in a heroic, high-risk effort to find the world's first surrogate marker for PC regression. However, they could have reasonably diverted money from their PR efforts into a core science effort focused on, at minimum, an in vitro assay that captures some of the in vivo dynamics, provenge gene expression or even simple cytokine assays as a function of time to later correlate with patient outcome, etc. What would this cost, a few $M/year? Of the 200+ employees how would anyone here break them down? Knowing the problems with the data and the ways for addressing them, you would think if they really had confidence in their product this would be job 1.
The amount of tractable science that could be done with the in vitro approach and the payoff in time scales and logicistics, aside from any product optimization issues, could be tremendous. The payoff from a promo video and sales staff or regulatory positions when the FDA and doctors just want data is questionable at best. Even more speculative science, that could show zero return, would have been well worth the risk ( it has some chance of working while a promo video and cartonn would not work against a rational FDA or doctor).