That's good to know GGB, what's unclear is when the FDA establishes a PDUFA date, does that become public.
I know there are sites that have the PDUFA schedule, but I believe they get their information from companies that state they got a PDUFA date. I'm uncertain if the company doesn't announce it if at any point the FDA does.
Because GBM is so deadly, if NWBO did submit to them, I'm sure they'd get the PDUFA date 6 months after it was accepted, I.E. priority review.
I frankly don't know how questions to the company are handled, but it's not a time out situation. If questions result in delays, the FDA will reschedule the PDUFA date, but it's not like the UK and European system where RFI periods can be off the clock for many months.
I've been critical of the FDA for many things, but I think the PDUFA date is superior to the other systems. The idea that we're over 1.5 years into a system that could gain approvals in 6 months, and the regulators are saying they're not beyond their allocated time seems to indicate that we've been off clock for the better part of a year.
For all I know, the company has agreed with all the regulators wished to do, the approval could be something that's far in excess of what we anticipated, but we really have no idea why it's taking so long.
I suspect that if this were the FDA, we'd either been approved long ago, or we'd have gotten the dreaded CRL from them which specified what more they wanted from the company before re-applying. I really can't say if we'd been approved long ago, or still busy working to re-apply, but it would certainly be a more defined process.
If by chance this has been done under Orbis, if in reality it will be a multi-national approval, and if that's information that can't be released until all the regulators reach an agreement, and act, it would explain why it's taking so long. Getting 4 regulators to agree to anything is a major task, but it would be a miracle worth waiting for.
Gary
Bullish
Market Data 
Markets 
