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Tuesday, August 20, 2013 8:20:57 AM
I also wish that CLSN was moving more quickly, but we can't force the overall survival (OS) statistics out, as many people in the trial are still living!
That's why progression-free survival (PFS) is used more often to gauge the success of a trial. It doesn't take nearly as long to get results, and they are more focused on the underlying pathology.
I'm almost certain that Celsion will need another lengthy trial for Thermodox approval here in the U.S. market. And it's unclear whether they will get approval in China without one.
I am just so "upset" that the FDA screwed up the design of the P3 trial. WTH were they thinking!?! They have cost people's lives and investors hard-earned money by their misstep.
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