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Sunday, June 05, 2016 9:42:42 PM
This essentially leaves us with a rolling review of data up until the scheduled end of the trial unless there is or has been some sort of an ethicist intervention. Linda said they would not apply for AA until the end of the trial. To me this means FDA is actively trying to decipher data which is accruing very slowly while perhaps also working with the other regulator time lines and manufacturing prep so that approval can be expedited if received.
You think there is a rolling review of a BLA going on right now, doc? For realsie?
Two things. If they crossed a stopping boundary for efficacy they would have halted the study and PRed the same. Or, if they needed to keep it going for OS they would have not halted the study and gotten it fully enrolled for OS while putting together and submitting a BLA based on PFS. And neither is happening here.
Not too late to try post # 61820 my friend! Or hey maybe it is. Data could come out tomorrow. Well if it's not you should drop NWBO like a dead fish :)
I remember one of the hardest things I ever reeled in ended up being a snarl of dead sticks. It took forever. The dead weight made it act like a big fish on the line that kept "slipping away" every time I stopped reeling.
"Think for yourselves and let others enjoy the privilege to do so, too."
-Voltaire
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