Wednesday, March 03, 2021 7:18:35 PM
As well as being a major step forward from Stupp 2005, from which emerged the SOC GBM treatment for the last 15 yrs.
Blinded, blended interim data has as much value as one wants to ascribe to it. If you want to consider it valueless, then that is your prerogative. But you really shouldn't be telling everybody else to think the same.
Your 'no accountability' claim doesn't hold any water. No exaggerated claims were made at all about the significance of the data.
JTM is open access. Anybody around the world can scrutinise and comment on or challenge any aspect of the paper. What more accountability do you want or expect!?
I would be happy for them to use the same journal for the final analysis.
The data remains the same wherever you publish!
There wasn't 'a lot left out' about PFS. They left all of it out!
But they said why.
And again, anyone can make of that what they will.
Yes there were always potential elements of data confoundment in eventual unblinded data analysis, due as you say to pseudo-progression and the crossover provision.
We knew that before and after JTM.
But the new primary endpoints as showing on the trial listing for UK and Europe, strongly indicate to me that the regulators in question have accepted them. Thus largely removing the niggling risk associated with possible confoundment.
And they certainly have met the new primary endpoint.
I am 100% sure of that, before they have even released the data!
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