Medical devices like pacemakers, heart valves, etc. -- sorry, you don't get a pass with life saving medical devices.
Optune trial met it's endpoints at the interim analysis and the FDA approved it .
Payer reviews are different -- "cost-benefit" Price of the treatment is a big factor in the determination. Payers don't like high cost treatments that they don't have budgeted.
If you read the SAP, it clearly details the cross-over that occurs when progression occurred. Patient gets a another full dose regimen of DCVax-L even if they had already been treated.
Dosing regiment was NOT a criteria for selecting ECA comparator trials using multiple dosing regimen. DCVax-L treatment arm got double dosing regimen, other trials didn't.
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