Jack, I find myself agreeing with your thrust here.
Regrettably, there is stuff they still cannot impart. Basically, anything that is sub judice, and that would appear to include the investigation report.
But, I expected more data from the conferences. There is more that they can and should impart.
There is no point in having an L info arm, if you don't impart the info.
So I want an update on the 25 indeterminate subjects.
Likewise with Direct. I'm sure Dr Bosch's presentation was very illuminating, but we weren't party to that.
I'd like to know:-
Where did the lost to follow-up patients come from?
As of this time last year (SMI 2015), there were no such patients. Now we have six.
This cannot be right. Two show as lost to follow-up in the first six months. Well why did they not show up previously? Is it safe to assume those two are now deceased? What about the other four? Someone is not doing their job right (the CRO?)
The progressive disease/stable disease at eight weeks correlates, are very difficult to interpret, when we are not entirely sure what happened when and how PD was determined.
'T-cell Infiltration can be associated with PD.'
That is akin to saying in some cases, the patient was taken off trial because the treatment was working...
SD at 8 weeks showed a correlation with survival with a p value of 0.01, but it might also be related to SD meaning you carried on getting injections...
And likewise PD at eight weeks (even if it was because of T cell infiltration) was an indicator of shortened survival, but was that because you stopped receiving injections?
The correlation between cytokine production and survival is clearly very significant, but, we don't know how cytokine production relates to dosage level or number of injections...
The highest dosage was 7.5 times the lowest.
The biggest uncertainty; Method A v Method B. Why has that been lost?
The survival difference as at ASCO 2015 was stark.
So I would welcome a full exposition of the final data. They don't need to draw too many interpretations (which is always an avenue for AF attack), but just get the data out there.
I'm ambivalent about the P2 plans. What I do know is they will only get one shot.
I want to know that they are carefully designing the most efficient trial route that would lead to the earliest approval.
The P2 plans as they have outlined are too vague, and on this point I would prefer they actually said less, until they have completed the rigorous planning.
Why mention the cyclophosphamide without giving a full rationale?
What is the rationale for a 'basket trial'? How does that support an efficient route to approval?
Have they considered a small targeted monotherapy trial for a single indication with obvious unmet need? Late stage Pancreatic comes to mind.
Such a trial without a control arm, could support European approval under the palliative provisions.
As BP know well, the important thing is to get your first approval, then work from that. Keytruda being the obvious example.
NWBO need to strategize with that aim.
The shorts are able to flourish where there is vagueness and question marks.
So NWBO needs to allay the uncertainties.
In other words, be selective about the 'radio silence' and wherever you can, get the information out there.
AI
