Replies to post #231868 on NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

I don't disagree that cross-trial comparisons are fraught with uncertainties.
But industry-watchers, analysts, regulators, HTA's, patient advocacy groups, message board chatterers, will all be doing it explicitly or otherwise, when this is unblinded. And if BMY release interim data from Checkmate-548, similar comparisons will be made. (Why didn't the FDA saddle that trial with a crossover?!)

On the info arm; the original definitions they employed were double rapid progressors and single rapid progressors.
The double rapid progressors (progression confirmed by a second scan) clearly were rapid progressors and I believe are all deceased.
But the single rapid progressors only had apparent signs of disease progression at one of the two timepoints,
These became known as the 'indeterminate' (not indeterminant)group.
Now I've completely forgotten what your premise is on this.
But the question for me is; is chemorad pseudo-progression a positive prognostic for survival?
Well, I'm not sure. Some of chemorad pseudo-progression is actually radiation necrosis. Does presence of radiation necrosis inform outcome at all? I have doubts about that.
You can argue this info arm issue any which way, to suit one's view.
I could, for example, point out that in EF-14, they waited nearly a month longer before randomization, to let in confirmed pseudo-progressors.
So all in all, I don't draw too much from indeterminate outcomes, as it might relate to trial outcome.

But the SNO data remains very promising at least to me.
And the long tail will be further elucidated after unblinding.

[iwasadiver]

AVII77 wrote:

Cross trial comparisons for time to event endpoints (like OS) are fraught with uncertainties. Nothing wrong with trying but you can easily fool yourself (that's why the FDA does not allow it for a claim of substantial evidence of efficacy)

Gunjur saw mOS of 27.4 months for his cohort of psPD patients (and DCVax saw only 21.5).

Tell me again why anyone thinks this stuff works.

Eh, what?? Practiceth what thou doth preacheth

[Dan88]

I rarely respond to posters like you who have said they have had no position despite posting endlessly 24/7 for year in this board, but I am sometimes no so strictly disciplined.

Linda Liau said in essence regarding those 100 patients who have lived over three years that "the majority of them not only live long term but also live progression free." [these are unprecedented, never seen in other trials!]

Based on the blinded data and subsequent update, it indicates it is highly likely that about 20% of all the patient population in the trial have lived and will live over 5 years.

Patients experience flu like symptom after injection of DCVax-L or placebo. Investigators will be quite sure how things are going from MRIs, blood analyses regarding possible immunogenicity activities of patients due to, oh, not placebo plus stand of care, but DCVax-L.

Adequately more data and evidence strongly indicate DCVax-L is safe and efficacious.

So chew the information, slowly and conscientiously, for I don't want your reply.

And please come to this board and let me know what's the result of your chewing after topline data is released, which I believe may come in August the earliest, and Nov the latest.