Replies to post #287166 on NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

Thanks Senti.
'Wreaks havoc'.
Yep that was it. How could I forget?!

We really don't know what is the status of PFS in the final SAP.
I'm inclined to think that the 'emphasis' is more on OS now, but we really don't know about how the alpha split might have changed.
It seems sensible to assume they ran the trial as long as they have done, because they believe they need the very mature OS data.
And we don't know what the regulator(s) attitude is about accepting an adjudicated PFS outcome anyway.
As I've said previously, the little hints, if there are any, suggest OS is the main focus.

But I might be wrong.
A lot depends on what the DMC did report to the company after the putative efficacy IA.
There is still the possibility that the DMC unblinded look found that the data was overwhelmingly good at that point, and that is why a regulator might have advised that all further recruitment was to go to treatment (or so it seems).
That's the glass full interpretation, and it has never been disproved.
But personally, I don't think that is what happened.

[Hspooner]

Senti, I was at BMS working in oncology at that time pseudo progression was a really big deal for all immunotherapy treatments, BMS was ready to give up on Yervoy, until those patients that progressed based on pseudo progression came back to their doctors with reduced tumor burden, I heard this directly from the investigators mouths. Pseudo progression was just coming to light at that time. IMO, that is what the issues were with DcVax, LP has never stated that fact due to the onslaught of nefarious forces. DcVax works really well in these patients, NWBO could not say that or it would have compromised the trial. Pictures are worth a thousand words!!( click on the link)

" His oncologist warned us that while on the med, his lesions could get worse before they get better but it is so hard to have hope when all we see are lesions getting worse."

Pseudo progression with Yervoy an Immunotherapy 2011

https://melanoma.org/legacy/find-support/patient-community/mpip-melanoma-patients-information-page/so-hard-remain-hopeful-yervoy