NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

Yes, I thought I was on safe ground saying that...

But, if they learn from experience and get the trial design right and pick the right endpoints and avoid clinical holds, I think 5yrs from today is not unreasonable. Recruitment will be fast especially if they opt for a single arm. These are going to be late stage patients with very few options. They probably won't be able to get to first line until a few years after that.
Let's be honest, if the regulator backs them like they did the Car-T's, then it definitely realistic. But that is a mighty big 'if'.
Does P1 to P2 to P3 really mean anything these days? Don't think the Car-T's ever had a P3.
And something else was approved after a Phase 1(b)!

Of course all this is dependent on L approval. But if they achieve that, I think, one way or another, the cash avenues will open up and the runway will be clear. At least to start with.

I was thinking about what they might use as a surrogate, so as to stand a chance of AA. And as you know, I don't like Objective Response Rate after 5 mins of treatment, because of how it doesn't correlate well with survival. And I honestly wouldn't want Direct (or L) approved, if it wasn't justified by solid evidence.
Maybe they could go for something like ORR at 12 months? As well as OS at OS12 and OS 24.
ORR at 12 months would take them past pseudo-progression hopefully.
And the last thing they would want is another goddamn trial with results muddied by pseudo-progression!

And maybe some sort of basket trial with smallish numbers of different cancers.

Just thinking out loud really.