NorthWest Biotherapeutics Inc (NWBO)

[AVII77]

I don't know, hope AVII chimes in.

My view:

For endpoints like OS and PFS, the FDA wants (insists) on an "event driven" analysis.

The following are not event driven analysis:

"The data will be analyzed once we have completed the SAP".

"The data will be analyzed once we have sucked every drop of money possible from the company"

"The Data will be analyzed once all our investors are long dead".

OK, there's some hyperbole in those second two.

But yes, "event driven" is what they want for a trial using a time to event endpoint that seeks to make a regulatory claim.

That can be tricky, even impossible, at the point in the trial where they are at now.

I confess I do not know why they insist on that. But I have seen minutes from several EOP2 meetings discussing P3 trial designs where the FDA told the sponsor things like:

"The efficacy analysis of RFS should be based on an event driven analysis, so the specification of “subject will be followed for up to 5 years after randomization, or until 80% of the subjects have an RFS event, whichever comes first” should be removed from the description of the primary efficacy analysis. If the number of RFS events has not been met by 5 years, you may need to consider a longer follow-up for disease assessment."

"The Sponsor clarified that the primary analysis would be conducted at 184 events, and 5 years of follow up would accrue for additional analyses. FDA agreed with this plan."

Don't be surprised if NWBO's primary analysis is done on the original 248 progression event target (perhaps with some new censoring rules that censor psPD events).