So you are implying then that they have been misleading everyone when they said RA's almost 3 years ago, and will be working with consultants for FDA (or other RA's , can't exactly remember the wording used) .?
First of all, they never said they will submit a BLA with the FDA. There are more regulatory authorities than just the EMA, FDA, and MHRA, you know such as the Health Canada and the TGA so there are your more than 4. It's posters like you who turned it into “the FDA”—they never said that, you did.
Second, according to the American Brain Tumor Association, they have a slim chance of getting a BLA approved without PLD, and I trust the American Brain Tumor Association on that. Even Powerless, after paying $10,000 per hour on consultants, must know that by now as well. In my personal opinion, they will never submit a BLA to the FDA based on this medical trial.