Steady T, if there is one thing I do respect the FDA for it's normally meeting their PDUFA dates when set. Clearly as a therapeutic aimed at a deadly disease, DCVax-L would get priority review, so the PDUFA date would be six months after the FDA accepted the BLA.
As I see it, if the company felt certain the EDEN would be accepted roughly 4 months after BLA submission they could make the submission then, and have time for inspection of one, or more, EDEN equipped cleanrooms plus the additional capabilities required.
With no guidance from the company since the last Annual Meeting, I really have no idea how close they may be. I find that much that the regulators do to be tremendous overkill, but if they insist on it, they can delay almost any product by years. I believe that clinicians, like Dr. Liau, would be completely happy to use the DCVax-L made in the EDEN for their patients, they'd have no qualms about it's quality or efficacy, but they're not the regulators. To me it ought to be a crime, but I've seen blockbuster drug approvals held up for years because of questions asked by regulators that were never part of the initial trial criteria.
In my lifetime I've probably seen at least a dozen products I felt certain would be blockbusters, they all were, but some of them were held up for years, but in the long run, they were approved. I'm saddened by all the patients who could have used them, but couldn't get them because of the delays caused by the regulators.
Gary
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