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Wednesday, January 16, 2019 6:42:14 AM
I try to figure out why there is so much differences but I am not quite sure why there is so much as I used your SOC data, may be I made a mistake somewhere ?
My model is using an extrapolated log curve. You have to agree on the numbers on this log curve that they match your figures (if you have only 62% OAS at year 5 it will be hard to extrapolate, you need more points in time like 1 year, 3 years ... the more the better). Why log curve and not linear ? Because survival works like this ! Means survival dynamics is strong in the first years and getting flat after (which means basically that the weak die first and when they are all gone the strongs remain). I noticed you using a linear model for events ("23" every 3 months) to compute events per date, therefore I believe you don't take into account the flatness of the curve and this might explain the difference. In any case I agree with your overall statement.
Source for Feb 2017 is the chinese document : 75 events in the reporting period from Report No. 8 from CVM
"1) The company entrusted the director of the hospital's otolaryngology head and neck, Zhongyu Wang (???), to conduct {an open, randomized, multiple centres clinical trial to compare the use of Multikine (Leukocyte Interleukin, Injection) plus standard therapy (surgery + radiation therapy or surgery + radiation combined with chemotherapy) and the use of standard treatment in primary advanced squamous cell carcinoma of oral and soft palate cancer (program number: CS001P3; IRB number: SF14218).} By reviewing the registered clinical laboratory result, the case is listed on August 25, 2014, Zhong Rong Ren Zi Zi No. 1030020068 was approved.
2) The safety of the drug Multikine has not changed since the seventh safety review of the drug development report. A total of 208 deaths have been accumulated so far. During the reporting period, there were 75 deaths at home and abroad. This trial was suspended from September 26, 2016 and has been notified by the Institute for reference. It was released on August 10, 2017 during this report period. In addition, there were no new safety or efficacy issues related to drug treatment, and no SUSAR was involved.
3) A copy of the Multikine Drug Safety Development Report (Development Safety Update Report No. 8, Date of Report: 16 Mar 2018, for the reporting period from February 4, 2017 to February 3, 2018) is sent to you for reference."
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