Hoffmann, H-G works hard to cast doubt about everything. Many FDA decisions, and I suspect the same of the others, are so called presumptive approvals. I suspect that the SAP was submitted more than once to all of them, if they requested a change it was made and resubmitted. Each time a change was made, all got the resubmissions and all had more time to request additional changes, it could only be considered complete when all had their full review time and not requested further changes. That's how presumptive approvals work.
People routinely ask to be shown FDA approvals, and I suspect the same is requested of other regulators. The reality is many things have presumptive approvals, the companies have nothing they can show. If the regulator goes beyond their own deadline and requests a change what do you think happens, I'd be willing to bet that over 99% of the time they get it.
Of course when a BLA is filed it first has to be accepted, then you get a decision, it may be a flat out approval, or conditional approval, or a CRL requiring further action before they'll reconsider. It is one time the regulator does something that's in concrete. I suspect that if NWBO goes for a tumor agnostic approval the most they can get is a conditional approval, one which says you can use, and charge for DCVax-L in solid cancers, but additional trials will be required to confirm this judgement. I frankly don't know if it's possible to ask for full approval in brain cancer, or just GBM, and also conditional approval for tumor agnostic cancers.
Gary
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