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longfellow95

01/13/19 4:48 AM

#208190 RE: meirluc #208180

Nevertheless, this suggests that 46 months post surgery for the last patients is probably a very safe time for data lock since the attrition rate thereafter is going to be minimal. NWBO may decide to carry out the Data Lock earlier based on low attrition rates during the last several months. I am just guessing that the last reasonable time for data lock would be about 46 months post the last patient's surgery which coincide with June 2019.



Meirluc. Why stop your observations when people stop dying?
If you do that, you are failing to capture people who go on living!
OK so, median OS won't improve, but mean survival will go on improving. And OS48 and OS60 will beat earlier derived estimates but you won't be able to put any of that in your statistical analysis, because you have already unblinded. And then the longterm OS stats will become of academic interest only. (Except maybe to an HTA who might accept them.)

LP is not mistaken. There is an argument to keep this trial going and remaining blinded. But, there are several arguments to bring it to a close...

Personally, I'm not advocating one thing or the other, because I'm not in possession of as many facts as the company are.
But if I was, it would probably be a difficult judgement call to make!

sukus

01/13/19 6:25 AM

#208195 RE: meirluc #208180

I also believe there will be another positive news on jan 23. The company needs to be very very careful since they are not unblind yet. But a positive news which don’t jeopardize the trials is what is needed. They know more than we are and if they want the pps go higher then better provide investor with better communications.

marzan

01/13/19 7:10 AM

#208201 RE: meirluc #208180

meirluc, I like Dan's question about why 46 months. It is not 4 yrs or not 3.5 yrs but just short of 2 months for 4 yrs. I see your response too taking the Data lock to June 2019 to reach that 46 months of the last dosage or so. I think it is a bit too far to wait till June 2019 for Data Lock. I am hoping to see Data Lock around March so as to meet submission deadlines to ASCO 2019 or some other venue sooner. I respect your knowledge and all the tireless hard work you do in analyzing interpreting and extrapolating the open data we got so far and I really appreciate it you share with us all these good things. A Big Thank You to you.

ae kusterer

01/13/19 3:55 PM

#208230 RE: meirluc #208180

Meirluc:Can you estimate how many of the 331 were alive 3/31/18 , and how many are still alive now?