News Focus
News Focus
icon url

BioInfo

05/20/14 5:00 PM

#10789 RE: etienne555 #10788

NWBO management for sure knows exact enrolment, given their manufacturing facility receiving tumor sample and creating vaccine is a known data to manufacturer and possibly the NWBO management too.

I believe in NWBO when they say efficacy DMC review is pending, it could mean a long draggen on process debting whether to halt for efficacy now OR get more data to be sure! this could also be where crossover arm is in full action pending final review and may be they want to see how crossover arm does too.

I am frustrated but not going to lose my sleep over the delay as I collect more funds and buy into the weakness.
icon url

Evaluate

05/20/14 6:51 PM

#10803 RE: etienne555 #10788

oops ... see my post 10804 instead .....
icon url

Evaluate

05/20/14 6:55 PM

#10804 RE: etienne555 #10788

Actually it is not because of lack of confidence on my part. It is because of the frustration of realizing this stock could be doing so much better if the company provided more info and clarity.
Provide more details:
• What can you tell us about Ph III trial? Are you still expecting to receive the (outstanding) efficacy results (or do you now believe they will remain outstanding forever?).
• When do you believe 110 events will occur in Ph III trial? When do you expect top line results?
• What are NWBO thoughts on the trial design and PFS being a sufficient endpoint to justify a halt and requesting approval by FDA?
• What are NWBO thoughts on the 72 events of overall survival? Will these 72 events need to occur before the trial comes to a conclusion?
• What are NWBO current thoughts about a trial expansion? How would this impact the total number of enrolled? How would this impact 1st & 2nd interim, and would it add a 3rd interim?
• What are NWBO thoughts on how the Hospital Exemption may impact the Phase III trial participation in Germany?
• Where are we at with enrollment in Ph III trial?
• What is the update with expanding into additional centers of excellence in Europe? Will these sites be added to have more patients enroll to achieve the 312 patient size? Which countries will have these centers added?
• What is going on in Great Britain? Might a similar Hospital Exemption possibly occur there soon? How about in other European countries?
• How many additional PR's regarding -Direct will NWBO publish prior to ASCO?
• Will NWBO publish a PR during ASCO?
• What are NWBO intentions for the large booth space at ASCO? Will NWBO provide very precise and detailed updates on all outstanding questions that investors may currently have, or will NWBO only speak about the trials in generic or scientific terms?
• When will NWBO start conducting quarterly calls for their investors?
• What will the profit sharing between NWBO & Cognate look like if the DCVax products are approved and go to market?
• Is pseudo progression a possible factor in the current trial?
• Is NWBO considering a request for Accelerated Approval?



I imagine that you are right that the management knows where they are going (or at least think they do). However, I think they need to do a better job of informing the investors etc where things are and where things are going.

I do not understand your zip code suggestion HOH OHO? RA RA RA? WHO WHO? MMM MMM?