Nice little write-up on Comet 1 @ targetedoncdotcom...posted 11/1/13
"The 960-patient trial is under way at 270 sites worldwide and has an estimated primary completion date of March 2014. In preclinical studies, cabozantinib has shown powerful tumoricidal, antimetastatic, and antiangiogenic effects, including extensive apoptosis of malignant cells, decreased tumor invasiveness and metastasis, decreased tumor and endothelial cell proliferation, blockade of metastatic bone lesion progression, and disruption of tumor vasculature."
Comet-2 started half year ahead of comet-1. In non-English speaking countries, there were no holding 2 for 1. Even in English speaking countries, the trial sites are not the same. So we can assume there were some comet-1 enrollments. Now with all patients pushed to comet-2, we may have full enrollment in a month(2 months after comet-1 full enrollment) or so if 100 enrollments/month work the same magic.
The interesting thing is that nobody is talking about EXAM. It's been postponed from march to 4th q of 2013 and then 2014. If the trend of 42% to 75% of events continues, we will have bigger and bigger ratio of survival patients between on-drug/placebo . So the longer we wait, the more favorable OS will be. Seems nobody cares, but it's really good sign for other indications.
Predictions are great for MB discussion, but OS trial design and results will be based upon post-survival events (ie, patient deaths). Can't rush that...longer is better. Like she said...
Have a great weekend!
Mgmt made it very clear on the CC that there would be no pivotal trial results, interim or otherwise, in 2014. I'm sure there are some smaller catalysts that could happen between now and then, such as EMA approval, but it sure seemed as though this gave all traders a free pass to manipulate safely until January, at the earliest.
More waiting, and for me, more buying. GLTA