The trouble is Sukus, getting my approval isn't worth a bean and won't move the dial at all, unless it's backwards!
If you were looking at OS60, you really have to to look at cross-trial comparisons, rather than with SOC.
And Stupp did 9.8% for his pivotal trial treatment arm (which is now SOC). Which was suspiciously good for the time.
And when, a few years later, that was the control arm in Optune EF-14, it only did 5%.
Somehow, the Optune treatment arm 'achieved' 13%.
You really can't compare our trial result with typical OS60 'in the real world', because in the real world, patients tend to be older and sicker. Weak immune systems, poor blood counts, older, comorbidities etc etc.
So you won't hear me talk about 400% improvements.
But notwithstanding the above, my calculated guess for L treatment OS60 of 20-21%, if born out, would be better than anything else previously, and I'd be amazed if any current trials like the Inovio one could match that. Not that we will find out, because they will end their trial long before they get that far.
Of course, if L treatment returns 20% or better for OS60 and it is accompanied by perfect safety and a decent maintenance of Q of L, then it should be approved, despite the actual trial design shortcomings.
That would be double the pivotal Stupp figure and 50% better than the Optune figure.
But should and will are not always the same thing.
Survival extension along with Q of L (living longer and / or better) are the only outcomes that matter to a patient.
And regulators should make decisions in accordance with that.
If there any fair and objective regulators out there, who actually believe in the importance of patient-centred, real world outcomes, then things would look good.
JMO.
