Replies to post #279910 on NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

Hi hyperopia.
Sorry if I took your previous post off in the wrong direction.
LP did say that the remaining individual patient data queries, some of which necessitate an onsite visit, had indeed been held up by Covid.
Though to be honest, I would have thought that all deceased subjects who died more than a few months ago would have had their file checked and scrubbed and pretty well locked anyway.

But obviously with the remaining surviving subjects, they will have to continually update records right up to the wire before datalock.
But when they achieve datalock (forgotten their time estimate May/June?), they will then be back in control of the timelines and the CRO role will essentially be finished. And the stat analysis, the Steering Committee and SAB advice, and then the general conflab leading up to a topline readout shouldn't be affected by Covid slippage, assuming that everyone has a phone and is connected to that interweb thing.

So, post topline, then what happens?
Well, first of all; is the data good enough for them to state 'we are moving forward to a BLA submission'?

If the topline announcement is basically 'did not meet stat sig on primary endpoints, further exploration of the data is continuing' it pretty much means game over as far as this trial is concerned.
But that's putting the worst outcome first.

If we get any variety on; 'endpoints met, we are now moving forward towards the submission of a BLA' then that's your next question. How long?
Even without Covid and being realistic, topline to BLA submission is probably at least five or six months. Some will say it needn't be that long, but that's what I think.
But I can't see how Covid would delay it too much.
This is the 50,000 page job of which a tiny fraction is the efficacy data, the rest being humungous amounts of CMC records.
And yes you can pre-meet with the regulator before BLA submission to get an idea if you've got everything in the BLA that needs to be there.
And then once you've submitted your BLA , you wait on the FDA.
And wait.
And hope you don't get a Complete Response letter that tells you there is something fundamentally lacking (in the regulator's opinion) with your application.
Though I have noted that many companies relay to shareholders that the FDA have indicated when a decision will be reached, be that 6, 8, 10 months or whatever.
I don't even bother calculating a timescale for a decision on a BLA. I just know it ain't any time soon.

But obviously the topline PR is the point of very high interim importance.