Tuesday, February 12, 2019 6:24:09 AM
Thx again for your perspective.
Logically I don't see how a category called LTFU can be reported by adding them to either the survivors or the events or both, since LTFU means there is no current knowledge of their status, hence LTFU. Logically it seems appropriate to always report LTFU as such and is a third category which should always be reported because they affect the numbers to a degree. However I did not know the convention for reporting LTFU at conferences. Concerning the KM curves, I thought the hash marks were used for both events and for LTFU but only the events accompany the hash marks with a step decline. However this is not my area of expertise, I can only use logic and reach out.
This is another area of question that NWBO has left on the table. I was ok to forget the LTFU and follow Dr. Bosch's explanation that led most to believe the company was close to 233 events back in 6/17. However, "upon further review" I agree with your perspective and I agree with the grammatical analysis by Lykiri on the words as presented in writing, associating the LTFU with the events, as NWBO presented the numbers.
I also agree with you that the randomization would not be allowed to veer so far off course and would have been self-corrected centrally. They are using two CRO's but Paraxel is the international CRO, who is quite reputable and established. It is not atypical to use two CRO's and coordination is to be expected.
Thx again.
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