Placeboed- couldn't agree more. A sober assessment of the situation -thanks for imparting a dose of reality here. Good to hear from somebody who really knows their stuff.
Fully agree FDA nobody's fool. No doubt one or two SH will say things like "yeah but just read those company ANNs, device is showing statistically superior to X, Y, Z, and whoa! prolongs survival so surely FDA gotta agree blah blah blah...." but we know that's all based on an unusuaL indirect comparative review which might just be accepted by BIS for CE, but I'd be prepared to bet if company took it to FDA seeking approval would be laughed out of Washington DC.
@Abloke- the company has previously announced the design of their pivotal fda trial- 300 patients, locally advanced PC, with 150 randomised to the Onc device plus chemo (gem-abraxane) and 150 randomised to same chemo only (control arm) - gem-abraxane. The interesting thing here, which surely the company must have cottoned on to by now from its expert advisors, is if those trial arms follow what current trial data indicate. So if the Onc arm matches Panco result and gets median survival 16 months, and the gem-abraxane arm matches what Celgene has shown in their recent gem-abr LAPACT trial also in locally adv PC (about 19 months).....well this potentially portends a negative pivotal trial.
(20min delay)