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Re: Evaluate post# 55940

Thursday, 03/03/2016 7:41:21 PM

Thursday, March 03, 2016 7:41:21 PM

Post# of 698579
4524, 4731, 4526 plus other related posts on IVIL. 4731 has the enrollment table that I used along with the KM charts for various medPFS. I did not nor will I model OS. You will have to create your own excel charts with the enrollment estimated data and the various KM charts to get the different PFS events per quarter. Just remember that it all starts with an enrollment table which was difficult for me to estimate for this trial. My observations from running various scenarios for different target dates are included in the related posts on IVIL. No need for me to repeat myself here again. But in my strongest opinion the modeling highly suggest that 149PFS events occurred around the time of LP making her announcement in May 2015 and taking into consideration the time for the DMC to gather the data and meet for the IA in the summer, IMO it correlates well with the timing of the temporary halt to new patient screening that later was updated to a partial clinical hold. My speculation is that a DMC recommendation of some kind was made to the sponsor who then initiated the halt and data submittal to the FDA.

Also, I do approach biotech w/ half cup empty just because the odds are against success. If you don't appreciate that risk, then you are likely to get burned repeatedly in this sector. JMHO. NWBO on the other hand IMO is not a typical biotech company. Due to the lack of transparency and potential red flags, it has to be handled with even extreme caution- including MBs.
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