I frankly don't remember who, nor do I know the source, but a very knowledgeable investor, who I believe lives in Europe, posted that no information had been requested from the company. I believe that was the case, but of course it's possible that it isn't. I suspect that in a 1.7 million page filing that is believed to have been in a rolling review, all the UK wanted was handled in the discussions or can be found in the submission somewhere. I'd hate to be the one that needed to find it, though I suspect a search routine will find nearly anything within all those 1.7 million pages.
I don't believe that the company would tell us if there was a delay because of information requested, just as they didn't tell us of formal acceptance of their submission. I would guess this would also be true of nearly all the other biotech's, so lets not make a big thing out of what the company does, or doesn't say. They will tell us if the UK approves, or if not and the reason why. I still believe the likelihood is in the 90% range, but I'll never be able to explain some of the delays caused in the past by our FDA, but I've seen blockbuster drugs that had tremendous benefits delayed by years by the FDA. I believe the FDA has improved in recent years, but no matter how good a drug is, you can never be 100% certain of approval.
I certainly have no personal knowledge of anyone making the decision in the UK, nor have I attempted to gain what should be proprietary information from the company, but I do believe that there are people here who may have such contacts. As I indicated earlier, I suspect that some of the BP's, with their industrial spies, may know the regulatory outcome before NWBO does.
Gary
Bullish
