It's a simple statement they can make that inspections are completed and no further RFI is required . They have commented on inspections in past and also stated "no news is good news ". And what happened to " we will have lot more to say later in Fall'". And it will be a very different company beginning of this year . When you make those statements and don't follow up , it is time to hold them accountable . It is time to call out BS
If six months ago the company were told, we'll approve you for GBM, or we'll consider more evidence that a tumor agnostic label, if you're willing to delay approva
If this situation were to transpire, it would be unprecedented even among the actual tissue agnostic approvals, all of which came with a biomarker by the way.