Biosect and BB,
It's very clear that both of you know far more than I ever will about how things work in the industry. I bring up what I do in an attempt to both understand more, but also to bring up possibilities that could explain why it's taking so long to get a Journal to publish.
It would be my guess that if the Journal was holding for FDA action, the company and the clinicians would be told that's what's happening, and they'd accepted it. Who knows, they could even be communicating with the FDA, but such communications are rarely revealed.
If the pure intent of the Journal is to reveal only what happened in the trial, then what the FDA is doing would have no bearing on what the FDA was in the process of doing. On the other hand, if the Journal is discussing the path to regulatory approval, then the FDA actions, or lack of them, could be of major importance.
I may be wrong, but I believe that our trial is one that's leading to major changes in the way the regulators are working. If that's true, then a Journal that fails to point this out has only done part of the job, as I see it. If you look at all the changes that occurred during the trial I think you have to wonder how many companies would have successfully navigated this minefield. I suspect that many would have throne in the towel, those with the funds would have begun a new trial, based on lessons learned, but many others would have gone belly up. I really believe all of us need to give everyone involved a great deal of credit for getting us here.
All the credit shouldn't go just to the company and clinicians, I think it's also clear that the regulators played a big part. The changes they agreed to may have been totally logical, but I've seen other trials where regulators wouldn't allow logical change, and insisted on additional trials being done to prove what was pretty clear in the original trial. I believe a great deal of time was taken in getting all 4 regulators to agree on many issues, but they did reach those agreements. While I'd like to see them all acting more dynamically, there is no doubt that they were willing to listen and act in permitting all the changes that occurred in our trial.
Gary
