Friday, May 16, 2014 2:38:35 PM
* what is current status of German reimbursement negotiations .... any progress at all?
* current update regarding enrollment in Phase III trial ..... in US & in Europe. Number of patients? Update regarding any new Centers of Excellence ... which? When will they become operational?
* explanation of impact of German Hospital Exemption on Phase III trial efforts in Germany
* update regarding the comment during March 2014 presentation about NWBO possibly considering expansion of the Phase III trial
* provide clarity regarding how future revenues/profits might be shared between NWBO and Cognate
* OK .... so why has NWBO been silent about 1st interim efficacy analysis? Most recently I believe NWBO still considered it to be "outstanding" ... but is NWBO also still expecting it to be forthcoming? Soon? Prior to 2nd interim? Oh, and when does NWBO expect 2nd interim of 88 events to occur?
* Does NWBO still anticipate Phase III trial completion in September 2014, as per clinicaltrials.gov, or does NWBO currently believe it might take a bit longer?
* When does NWBO anticipate a DCVax-Direct to complete Phase I/II trial (60 patients, including 24 patients in 1 selected type of cancer?). Does NWBO anticipate a Phase IIB trial with 24 patients for each of the 6 various cancer categories, for a total of 144 patients?
* Please provide more info on Label Extensions (for -Direct? for -L? for both?)
* etc ....
So who wants to cough up the ASCO entry price and go get some answers?
Recent NWBO News
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