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Monday, February 15, 2021 12:23:15 PM
so complex it takes a genius, but it is not. The time consuming
part is the data scrub and cleaning part, once the data base
is locked, all the endpoint data are represented in numbers
in the data base, and they are pre-specified and agreed with FDA,
CRO should be ready with all the software modules ready to run
the data base once it is unlocked and unblinded, these endpoint
data should be printed out in minutes, rest of called detailed
full data are patients profiles, safety data, any imbalance of
enrollments, subgroup data of geography, reoccurrence treatments
like how many have Keytruda...I can do it in days, I do have
a degree in computer science. Please take a look at the example
Sushi give us and see if it need 4 month to do the job, especially
Geert says experts are doing the analysis which means CRO has done this
kind of job tens or hundreds of times:
https://www.dropbox.com/s/cnku7it96z42mg5/Baas%20et%20al.%20Meso.%20CM%20743.%20IASLC%20WCLC%202020.%20Oral.pdf?dl=0
Most of the knowledgeable NWBO longs agree NWMO management
got the full data between early NOV to early DEC, no TLD PR
is because they changed their plan to publishing the data
with TLD at the same time.
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