which is incorrect...although i am somewhat skeptical that two cycles will make alot of difference even in chemonaive patients perhaps it could fall to 11% but hopefully increases to 15%
It was 17% in phase 2 chemonaive and most of them only received 1 cycle or less. 10 of the 15 phase 2 responders needed at least 2 complete cycles before responding (one responded after 7 cycles) so the improvement in response rate should be substantial now that everyone gets at least 2-3 complete cycles.
OF- Talk to the FDA. They by definition delay "good things". The current known information points more likely to success than not. The ways A-7 is not approved are either - (1) the control arm vastly out performed statistically known survival rates (indicating a huge anomaly) or (2) the trial's construction is defective in relation to measurable and statistically meaningful benefits. On first point, I would not want to betting with the control arm outperforming statistically known outcomes. On the second point, assuming the first is not the case, Id rather bet that the trial was properly constructed to capture actual benefit.
It would seem that logic and probability lays on the side of longs, and superficial statements and quips belong with the shorts on this one. Of course, you never know until you know.
Sentiment: Strong Buy
Thank you for your contributions -- there is not irony in my statement -- you are performing a useful "opposite view/resistance" function. You might consider the downsides of becoming too obvious.
February 16, 2010
ONCEPT is the first and only USDA-approved, therapeutic vaccine for the treatment of cancer — in
either animals or humans.
Traditionally, dogs with stage II or stage III malignant melanoma survive less than five to six
months when treated with surgery alone.1 Clinical studies of ONCEPT demonstrated significantly
longer life spans even in dogs with stage II or stage III of oral melanoma. In fact, median survival
time of dogs treated with ONCEPT could not be determined because more than 50 percent of the
treated dogs were still living melanoma-free at the conclusion of the study or died of unrelated
To view the survival curves, Google:
"The first DNA-based canine cancer vaccine, now fully licensed by the USDA”