Other drugs that have been much more expensive with nowhere near the potential benefit have been approved. They will weigh many factors, not just the price. Price is important but given the core measurements for survival including recent data in the comparison, it is doubtful they would want to be seen to be withholding this from patients.
And on an ongoing basis, treatments at a doctors office not the hospital, virtually no side-effects and none that require hospital treatment, low maintenance, the cost monthly is not just competitive with treatments that are given frequently in the hospital with terrible side-effects that require additional care, but it is substantially less, with way better quality of life and providing a substantial survival benefit that looks likely to grow immensely with poly-ICLC and other potential combinations.