I'm not sure if both of you aren't right. In October I have a feeling the company did say something like the document was ready for review, both in house and by contractors, but it wasn't a submission to the regulator.
It was submitted late in December, preliminary validated in late January, and not finally validated for a couple more months. What difference does it make as to what we believe the start date was.
If the regulator is saying they're still on time, I guess that's saying they've not yet spent 150 days that were considered to be on the clock. I guess it's up to them to say, this day is on the clock, this one isn't, it's their clock, so they're in control of it.
The company had said that they'd yet to receive a RFI well after the time the guidance said they should, regardless of which start date is chosen, so apparently they could have some off the clock dates even while they're the only ones dealing with the filing.
For all we know they could make a decision tomorrow, or it could be six more months, and they would still say they're on schedule. Apparently, whether it's a member of Parliament, or some other official that asks, saying we're on schedule get the job done, regardless of how long it's been since they started.
Our FDA doesn't always meet their PDUFA dates, but they do officially reschedule them so a new target is established. Other regulators seem to all push for 150 days on the clock with time off for RFI's, but don't seem to care if it takes years to finish the process, they just say they're on time.
I don't care if it's the FDA or other regulators, they're the judge and only a fool criticizes or questions the judge, even after a trial, if it's believed that some day they may be judged again.
Gary
Bullish
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