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Re: meirluc post# 121027

Thursday, 06/08/2017 4:43:08 PM

Thursday, June 08, 2017 4:43:08 PM

Post# of 701946
meirluc,

Dr. Bosch mentioned a time frame that puts the last patient enrolled in the earliest part of November 2015 based on a June 5th presentation point of referrence. The 66th PFS event was announced in December 2013. The midpoint of trial enrollment occurred in May 2014. The enrollment rate then was about the lower mid twenties per quarter if I recall correctly. So ~167-~41=~126 enrolled at the end of 2013. Someone may be able to correct me on this if they have a screen shot of the enrollment chart Dr. Bosch recently shared. If there is no corrrction, this means 66 PFS events occurred out of ~126 patients enrolled between 2008 and 2013 with most having enrolled from the beginning of 2012 forward. A median enrollment month for this group most likely would have been in October 2012 or in a month on either side of it with late September to mid November being most likely. October 2012 to early December 2013 is roughly 13-13.5 months depending on exact dates. This then is rougly the median blended group PFS eventing time. This event time was also one being reported multiple times annectdotally on this message board based on public patient accounts. Dr. Bosch, in his recent presentation, reiterated the standard SOC event rates and suggested once again that these have not changed much. These rates are much lower than 13 months. We can not put much into this as his duty is to tow the company line but he did not suggest anything unusual had been seen in trial PFS event rates while he did note that OS rates were slower than anticipated. Trial enrollment criteria may help SOC in the early part of the trial while later lowered absolute lymphocyte count for patients in Germany probably helped neutralize that advantage to a small degree at the end. A 13-13.5 mixed PFS is probably too close to call once factoring in potential early SOC trial inclusion criteria so going to observed trial strength and allowing PFS data to strengthen before unblinding it and OS makes sense. I really like what sentiment_stocks recently wrote about PFS but I always like to keep in mind the weakest link. Best wishes.
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