NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

I'll try and comment on both your substantive posts.

So why doesn't LP just say so.

Well, the trouble is that is pretty much an unanswerable question, unless LP takes us into her confidence...

I think it is fair to assume that NWBO have had several interchanges with the FDA and the SEC. With the FDA, we know they have had dialogue about the partial clinical hold. Because we don't know the nature of the hold, how can we possibly know whether the silence on the issue is warranted. What if the hold was related to criminal interference in the trial? Data bank infiltration for example.
That would possibly lead to a requirement for silence if the FDA and the SEC were investigating trial-related matters.
Now that might be a fictional conjecture on my part. But, I expect the truth is even stranger than the fiction...

I don't see the logic in completely condemning the apparent disregard for shareholders right to information, until I know why it was the case.
And only then will I decide if it really was justified.

I do think they could do a better job of identifying any information that can come into the public domain and getting it out there. And just ringfencing what is necessarily embargoed in agreement with regulators.

They have probably had negotiations about how to go forward with the issue of patients, having been deemed to have progressed, when in fact they have had pseudo-progression. Now, as we all know, that's the primary endpoint...

It's a critical issue to the success of the trial. But I do think (hope?) they have reached some sort of equitable resolution with the FDA about how progression decisions can be re-visited.

And they make mistakes! They PR'd the investigation, saying that they anticipated it would take at least 3 months.
They probably shouldn't have mentioned it in the first place, but once they had, they should have realised that shareholders would expect updates.

And the publication! They knew that trial topline was way away, so they commissioned something that would reflect very favorably on L, maybe about Q of L, patient reported issues, real world outcome measures, etc etc. Something that would serve to plug the gap until they could report on endpoint topline.

So I think the intention was good, but it has backfired on them. There has probably been at least a couple of thousand posts on this board, about when we can expect the damn publication...

If Dr Bosch hadn't mentioned the idea, it wouldn't have become an issue. Instead, it just becomes something that naysayers can be cynical about all day long!

As for the SEC, well, who knows what is the extent of their interest? I do think their investigations are broader than the naysayers would have you believe, and that a lot of those investigations involve the actions of third parties.
It's just a hunch on my part, but again it could explain the requirement for silence on quite broad issues.

And of course, LP has the experience of previously being open with their PR, which only resulted in short-inspired critical onslaughts, followed by a raft of lawsuits.
'Once bitten..', as they say.

I don't know the reason for management's abject lack of transparency. I don't know the reason why the publication has yet to come out. I don't know why LP is hinting to a possible Fall data collection. I don't know why LP is emphasising the long tail interest shareholders should have, except to say that it is possible that she is trying to divert attention from the trial endpoints, etc. One can only speculate.

Well, I think you pretty much go on to answer your own questions, or at least rationalise the situation as best you can.
Which is what I do.

And there is a lot of congruence between your views and mine, I believe.

I like your psychological characterisations of LG and LP, and I think an appreciation of their personal natures is an important part of the jigsaw. LP is completely single-minded (almost certainly to a fault.) I have to say although her delivery may be bland and boring, the content rarely is, especially when she goes into spontaneous mode at shareholders meeting for example.
The one-liners are becoming legendary...

Pretty much agree with all the rest of your analysis.
Personally, I doubt the nefarious intent that you speculate about towards the end of your post.

On the kicking the can down the road indefinitely; I don't think they're doing that. I think they have a specific data target in mind, which may well be 75% OS events. Which is when only 83 trial subjects remain alive.
That could be today, tomorrow, next week, or next month, but not much beyond that.

The alternative metric is 36 month milestone survival for the whole cohort.
No need for forward estimates of survival, based on proportional hazards assumptions, that are clearly not proportional.

That will be available in Nov..


Beyond the end of the year, they cannot go.

For credibility reasons, and because they have a certain lack of required resources.


And LP is basically getting Advent up and running from the other side of the pond, which is a huge undertaking.

They can operate from the Royal Free CCGTT for now, but Sawston has to be licensed, with a named qualified person, and some remedial renovation is required (not the environmental contamination bit; that will have to wait.
Advent has one production scientist who is newly recruited.


They are responding to individual compassionate cases under UK Specials, and now they will have to consider how best to respond to RTT in the US. They cannot allow RTT to be any sort of drain on resources.


They have their work cut out, in more ways than one..