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marzan

06/27/19 2:09 PM

#234847 RE: meirluc #234845

Thanks meirluc, agree that DI cannot share any material info over the phone before making it available to the public. What we are asking him over the phone is all material: like is the SAP submitted? is the soft lock in place? when will you unblind? Dr. Bosch clearly told to the rest of the world that they have few hundred queries left to complete as of June first week. First of all we all have to go back and reread the link Kam8 provided or Ex/AVII chimes in on what is meant by Soft Lock. The way I read it, it clearly states you lock the data on that certain date and do the queries on those data alone. Some posters here say Soft Lock means query is already done on them. No, I don't think so. So, in my opinion, I think Soft Lock has been on for certain time and the remaining queries Dr. B said must have been completed by now or close. I think they could set the Hard Lock or what one calls Data Lock any day now provided the SAP is done and right. The data in between Soft and Hard locks can still be included into the Hard Lock as the queries related to them can still be conducted in parallel process, imo. This is what AMRN did, imo; AVII or someone AMRN holders here can intersect if I am not correct. So undeniable fact according to me is Soft Lock is already on.
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meirluc

06/27/19 2:38 PM

#234852 RE: meirluc #234845

More about my talk with DI (that I now recall).

1. First I would like to repeat what I wrote a few minutes ago. Hopeforthefuture was right that if and when a data lock is installed it will no longer allow new results to be entered into the data base. However, no soft lock is yet in place. DI strongly hinted that a soft lock will be installed in the future because he hinted that there will be a period before data lock when no new data will be accepted (had to decipher the Rosetta stone for that).

2. I am pretty sure that there will be a soft data lock in the future but in the meantime we have the data almost all the way up to 47 months past the last patient's surgery.

3. Got the impression that DI believed that ALA was not extensively used in the last part of the trial and I believe he felt that would not be a major reason for improving the survival rates of the last third of the trial.

I also got the feeling that DI did not believe that any SOC treatment used in the trial including the improved surgical techniques was radically different than previous SOC and therefore on that account the survival results are not likely to be better than usual. Of course like us he cannot foresee the effect of the crossovers. Like all of us he is waiting for unblinding and then we all will know.