$XBIT: New released yesterday. Look for this stock
Post# of 23118
Posted On: 08/17/2016 8:27:36 AM
$XBIT: New released yesterday. Look for this stock to move higher for next several days. John Simard - Founder, President & CEO in his brief said:
I’d like to start with some recent highlights pertaining to our European study. In July, XBiotech presented data from the pivotal European trial for Xilonix at the European Society for Medical Oncology World Congress in Barcelona, Spain. An oral presentation was made there by Dr. Tamas Hickish and there we also met with key opinion leaders to discuss our findings.
It was a very interesting meeting sure there may be some questions to follow. More recently, we had an in person meeting with the European regulators in Europe to discuss our marketing authorization application, and the application I can tell you remains on schedule and we are currently devoting a good deal of effort to advancing the process.
On other fronts, we continue to move forward with our Global Phase 3 study in colorectal cancer. We call this our XCITE study, which is proceeding under FDA fast track designation. Our enrolment in this study remains on track and we anticipate completing enrolment around years’ end.
Recently, data and monitoring committee meeting was held following randomization of 400 subjects. This is a standard process to evaluate the study principally for safety and they found no safety concerns and allow the study to proceed as planned. Another DMC meeting is scheduled to occur after 600 patients have been enrolled.
The transcript is at:
http://seekingalpha.com/article/3999960-xbiot...transcript
I’d like to start with some recent highlights pertaining to our European study. In July, XBiotech presented data from the pivotal European trial for Xilonix at the European Society for Medical Oncology World Congress in Barcelona, Spain. An oral presentation was made there by Dr. Tamas Hickish and there we also met with key opinion leaders to discuss our findings.
It was a very interesting meeting sure there may be some questions to follow. More recently, we had an in person meeting with the European regulators in Europe to discuss our marketing authorization application, and the application I can tell you remains on schedule and we are currently devoting a good deal of effort to advancing the process.
On other fronts, we continue to move forward with our Global Phase 3 study in colorectal cancer. We call this our XCITE study, which is proceeding under FDA fast track designation. Our enrolment in this study remains on track and we anticipate completing enrolment around years’ end.
Recently, data and monitoring committee meeting was held following randomization of 400 subjects. This is a standard process to evaluate the study principally for safety and they found no safety concerns and allow the study to proceed as planned. Another DMC meeting is scheduled to occur after 600 patients have been enrolled.
The transcript is at:
http://seekingalpha.com/article/3999960-xbiot...transcript
(2)
(0)