and this:
During the quarter we prepared for pivotal trials with CYT387 while continuing to explore potential opportunities to further develop and/or commercialize our drug with other companies.
Our Phase III readiness activities have progressed substantially on all fronts. Over the summer months we conducted productive discussions with regulatory authorities in the US and Europe which have affirmed the range of options available for the pivotal program for CYT387. On the manufacturing side, we recently established the bioequivalence of the tablet formulation of our drug and we have manufactured a supply of drug for pivotal trials. We have also completed preclinical toxicology studies required to proceed into these studies.
We look forward to reporting final results from the 166 patient Phase I/II study of CYT387 in myelofibrosis in December 2012. We were pleased to report that these results have been selected for presentation in an Oral Session at the 2012 Annual Meeting of the American Society of Hematology, reflecting the medical community’s strong interest in this data. In June 2012, all eligible patients completed the core part of this trial by receiving drug for nine months and many of these patients continue treatment with CYT387 in the ongoing extension trial, implying that CYT387 continues to provide benefits over longer periods of time.
We are steadily advancing towards the initiation of pivotal trials for CYT387, to be potentially initiated together with another company. We have robust data for CYT387, defined market and regulatory clarity for our lead indication, and sufficient resources to remain independent if desired. We thank you for continuing to share our enthusiasm for the potential of CYT387.
Sincerely,
Dr. Nick Glover
President and CEO
YM BioSciences Inc.
Date: November 9, 2012
I believe longs will finally see some positive movements in the next 30 days.........JMHO
GLTA
johan
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