It's rare that I agree with you, but you're right, the Street is not acting like NWBO is about to receive an approval. The question is whether the Street is right, or wrong. Certainly people like Adam F are telling the Street it won't happen, again, time will tell who's right, or wrong. I still believe the Street could be surprised, but if not, if it's later in the year, I can live with that.
Eventually it will happen, the UK can say they're right on time if they use the final validation, perhaps adding time for information requested, even if not directly from the company, perhaps by inspectors, so the company could be unaware of such requests. I certainly don't know. The regulators can say anything they wish and practically never get a disagreement as to disagree is like criticizing a judge who's judging you. If 150 days takes over 300 days, and they say they're right on time, who'll say they're wrong.
I seldomly put the FDA ahead of the other regulators, but in the case of PDUFA dates, they are more firm than the times established by other regulators where no concrete date is set for action. The FDA almost always either meets its PDUFA date, or delays it by the time it's due to occur, so by the time of the date you either get a decision, or an official delay and new target date. Certainly some actions are taken before the PDUFA date, so even if they reschedule by 3 to 6 months they may act before the new PDUFA date.
Gary
Market Data 
Markets 
AI
