There was a lawsuit when Provenge was delayed.
I think the deal was that the review board recommended an early approval, with a pretty clear vote, and the FDA decided no. Protests and a lawsuit followed. One of the points in the lawsuit was that one of the people in the FDA that voted against the early approval was associated with a direct competitor.
Not sure it makes sense to anticipate a problem Flipper. But if something similar were to come about, it would make sense to contact the same legal firm that handled that lawsuit and also the major players that initiated the lawsuit. Since there were also protests against the FDA, we could track down the major players there. Probably best to locate the ones that don't have a bunch of stock in Dendrion.
But I just did a quick read on that last week. Could be remembering things wrong... and I don't know what the outcome of the trial was, nor whether there really was anything improper by the FDA. I do know that the path is paved for such action.
Hate to bring up Provenge because some consider it a failure. (It is an immunotherapy similar to DCVax-L for prostate). However, the failure is due to the high production cost. NWBO focused on production costs and is able to mfg DCVax at about 1/3 the cost of Provenge. That is a huge!!!!! difference!!!!!
So NWBO will likely grow into a large and successful company on it's own right if it gets through these trials. For that reason it might not make sense to sell all your shares if and when approval comes.
Further: By having parallel clinicals in Europe, NWBO gives a second path for approval. But it also creates a situation where the FDA would look very suspect if the results were good and approval was denied... because if Europe approves the therapy and the number of patients skyrockets, and the results are good and widely known, which they would be... then the world would turn and look the FDA in the eye and ask what is going on?
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