Monday, August 19, 2013 10:51:10 AM
In biotech, the destination is either a better standard of care or an outright cure for a given disease.
Unfortunately for liver cancer patients, the Celsion P3 trial was poorly designed by the FDA. It made no effort to use RF ablation time as one of the control (independent) variables.
IF a more focused follow-up trial using RFA as one of the control variables confirms the LARGE (42%) sub-group data from P3, then I'd say that writing off Celsion is abjectly premature.
I expect that we'll know what the FDA has in store for Celsion by the end of the year. Hisun and the CFDA are the "wild card," however, as over half of the world's HCC patients live and die in China. They are likely to move faster than the FDA, as the largest P3 cohorts came from Asia and China.
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