Daniel,
It sounds like you're answering one of my posts, I don't know why it would have been deleted, but apparently it was.
I can't disagree that the quiet period has gone on much longer than the company thought it would, but I can't blame them for doing what they stated they were doing, I.E. maintaining the quiet period until the Journal is issued. I believe it's largely out of their hands and frankly I can't say how high a priority it is for Dr. Liau to answer any questions or comments that come in from the Journal's peer reviewer. From what I've seen, Dr. Liau has a very active schedule, and I've got to believe that she's still operating on a fair share of patients between all the other things that she does. I'm sure the company is willing to provide support if she asks, but frankly I don't know if the company automatically receives an info copy of everything the Journal sends to Dr. Liau, or only what she chooses to send them. I believe that several here have been in similar circumstances, perhaps you can answer this question. I would think that Dr. Bosch would be listed as one of the authors, but I would think that most communications would be between the Journal and Dr. Liau, and she would be free to ask for the support of any of the others given authors credit.
In reality, I believe this trial was stretched out for years based on the slow movement of the regulators in accepting the changes that clearly were justified. Had PFS remained the primary goal, AdamF would have been right, the trial would have failed on PFS, though OS was secondary, and a case could have been made for it, but only if historical data was permitted as nearly all the control crossed over to DCVax-L so it didn't really constitute a control. I believe that not permitting patients to cross over, maintaining a true control, is something even the regulators couldn't agree on, especially when benefits could be seen, the German's took it a step further insisting that they not delay patients, eliminating the control group completely for the last several patients in the trial, all the other regulators eventually concurred.
There is no doubt, NWBO has forced the regulators to change the way future business is to be done. In the future I believe many trials will be run utilizing historical data for control and all patients receiving the experimental drug up front. I believe other companies efforts have also said this is how it should be done, but the DCVax-L trial clearly forced the issue and the FDA article in Annuls of Oncology makes it pretty clear that the FDA has agreed. The problem is, all these things have taken a great deal of time and even now it's unclear if something is being hung up until the FDA formalizes what they said in Annuls.
It's easy to blame LP and the company, but in reality much of this is out of their hands. When the company said they were in a quiet period until peer reviewed results were issued in a Journal I believe they knew it would take more time than if they submitted an Abstract for presentation at a major conference, but they also knew it would be much more comprehensive and leave far less for bashers to work with in denying the success of the trial. It's taking much longer than they thought, but they're doing what they'd said. In the end I believe all of us longs will be thrilled with the results. I don't think you'll despise her after the Journal is released, hopefully it won't be that much longer.
Gary
