It remains to be seen whether AA is used in this trial -- it's a tool. What the timeline is still remains a mystery, but it's fairly clear to me enrollment was complete around Halloween. The documents provided by NWBO back in September 2015 could have been, as I suggested back then, in the form of a rolling review, with the FDA unblinding the data for themselves initially. It may well be no formal application is applied for until there is a commitment on the other side, because data maturity is the best insurance.
It may be NWBO will not need AA if their data is strong enough. So, which route they will apply formally for is a decision to make at such time.
Not certain many others understand how AA works. It can be applied for at the first interim, and it can be applied at the end of a trial. The idea (in this case for instance) is PFS is the surrogate endpoint.
In NWBO's case, they began, enhanced and continued the trial during a time frame where the FDA was particularly vocal in their policy stance that Accelerated approval should not be applied for in phase II, but rather in phase III at the first interim, and the concept is that if the same trial is used as a confirmatory trial, Accelerated approval might be granted when the confirmatory trial is nearly complete, or at least well underway.
However, you must understand it is far better to simply be granted full approval, and therefore during a rolling review, early commitment to AA can potentially be a faux pas, and thus a close working relationship to help this process is critical.
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