As promised we have been collecting data on the quarterly basis. Our latest overall survival analysis was recently completed for patient data collected as of June 30. Now we would like to know with even more confidence that these data indicated substantial improvement over the control group in ThermoDox treated patients who had a RFA procedure greater than 45 minutes.
Details of these findings will be discussed and data presented at the upcoming ILCA Conference in September of this year. It would be very clear and in particular with retrospective analyses, any announcement of a trend or a positive signal has to dealt with some caution. As we have consistently pointed out much of what we are discussing has not met a threshold for statistical significance, and in the case of OS does not reach the median.
Regardless our experts and investigators believe these data to be important to the global HCC community and have been anxious.We conclude with some confidence that the data reflecting and optimize RFA treatment time, although not perfect is impressive enough to warn our friends to validate their findings which is in progress. And to hold discussions with FDA, which we would expect to occur early in the fourth quarter of this year.
The 21 of August we have this:
Professor Poon's presentation will include the most recent overall survival data. Recent HEAT Study post-hoc analysis, strongly suggest positive progression-free survival (PFS) and overall survival (OS) in ThermoDox® treated patients when heating cycles from the radiofrequency ablation (RFA) procedure were optimized.
In 13 days results became from 'finding' to 'official' with special mention 'strongly'!