The paid pump crew knows that, but their job is to build false expectations to string along more bag holders.
The IFR is a last resort and done on a case by case basis, led by physicians. No physician outside GBM is going to recommend this to their patients anyway. Either way, not many physicians will have the time and resources to do such paperwork on an ongoing basis and wait for the bureaucrats to approve. And importantly, the available fund in IFR is going to be extremely limited. Perhaps one or two dozen patients per year for DCVAx-L under IFR if they are lucky would be my guess.
That’s why without reimbursement approval this is never going above $15M in annual revenue. The fact that they haven’t submitted reimbursement evidence 5 years since data lock tells us that they are not confident, and therefore will continue to stall this for another year or two. Otherwise, no reason to not submit the evidence last year and have that be done in parallel.
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