Azixa is being presented as a "salvage" drug. The path to approval for drugs in this category is not orderly. Management is probably negotiating with FDA over what will be required; it is expensive bad form to talk in public while negotiating with FDA. It is even possible that marketing will be permitted [for GBM] before anything designated "phase 3" is done.
The big money is in treatment of brain metastases of "the big 3" (lung, breast and colon cancers). For those to become label indications it will take LOTS more testing. But a little income stream in the mean time would be welcome [and off-label use might make that stream larger].