I believe the allegation that NWBO hasn't been doing much since they received TLD will be found to be completely mistaken once the quiet period ends. Frankly the request to inspect the commercial production facility at Sawston is in and of itself a major accomplishment. Without such a facility, no approvals are possible.
I think we'll find that approvals are really much closer than we ever thought, but that's only because during the quiet period that's what they've been working on. The commercial production path was the critical path, and more than Sawston may be needed for all four regulators to approve, but once we have the first approval, almost certainly the U.K., the others may rapidly fall in line.
More people seem to be agreeing with something I suggested some time ago, namely the Journal would like to see the FDA formalizing the approval of using historical information, rather than a control group, to judge a trial. They certainly said it in Annuls of Oncology, but that's not a regulatory document. Someone said they're something like 9 months late in producing the official documentation, I have no idea when they intended to have this done, the FDA doesn't use a watch to tell time, they use a calendar, and + or - a few months is meaningless to them.
Is it possible that U.K. approval could happen before FDA documents are out, and perhaps the Journal's not out either, I hope not, but anything is possible. I don't believe the company could maintain a sequester imposed by a Journal and gain an approval without the Journal dropping some, if not all the restrictions they've agreed on with the company.
I believe a Journal is far more likely to criticize a regulator than a company looking to gain product approval from that regulator. Whether the Journal ever admits the primary cause of the delay, or not, I believe it's clearly out of NWBO's hands.
Gary
