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12/20/14 9:20 PM

#27228 RE: Rkmatters #27216

Also, maybe the company issue isn't the halt per say. It could be that the company really needs more time to get the Commercialization aspect of the regulatory decision squared away. We know they're on track in Germany on that front, but we can't say for sure that they're ready in the U.S. and the UK. No sense halting until they're sure they can pass the Commercialization portion. --- Rkmatters



This does not sound right to me.
I'd think that if NWBO felt the odds were 99% that a DMC halt recommendation at 1st IA (or 2nd IA) would result in FDA giving its approval, then NWBO would go for it, rather than spending an additional 8 months to complete the trial.
I think the FDA takes a while before they come back with their conclusion, right Pyrr? 6 months?
Once FDA gives their approval, then NWBO would still have the opportunity to get their commercialization squared away & would not be required to start until that was completed. Plus in the USA the Memphis facility should be able to handle the initial needs, right?