NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

In my gut I just have a feeling the Journal is waiting for official FDA documentation that authorizes trials to be judged using historical data rather than a control group. We know that the FDA said so in Annuals of Oncology, but that doesn't constitute being official guidance.

Companies don't complain about regulators, at least not publicly, and while they may have been assured by the FDA that the new guidance is coming, I could understand a Journal saying we're waiting until it's here.

If this were the case, neither the Journal or the company can do anything to expedite it. The FDA's action, or lack of it, doesn't prevent the company from filing with the other regulators, but the Journal documenting the success of the trial may want proof that the FDA, which generally is considered the gold standard, will accept the trial results and compare with the historical data being provided by independent experts.

I certainly could be wrong about this, I just can't think of other issues that would hold up issuance of the Journal if either the company or the clinicians could modify something requested by the peer reviewers before they'd publish.

Gary