Sunday, November 10, 2019 9:27:08 AM
Am not very familiar with the biotech world, in the learning mode.
The IA PR included these statements:
We believe this tracking bodes well for success at our next pre-planned interim efficacy analysis, which is intended after a minimum of 158 patient deaths.
“The hazard ratio for success at 158 events is 0.70. This is below the hazard ratio of 0.65 observed for the 285 patients in the HEAT Study subgroup of patients treated with RFA > 45 minutes,” Mr. Tardugno added.
To state that interim milemarkers if achieved, would be a success...the implication was assumed by some to mean the trial would be declared a success. It does seem to be a poor choice of words. Trials get labeled a success, don't confuse the landscape by using that word for an IA review.
Yes, in reviewing the Heat study and working at coming up to speed on Celsion, it does appear that the study ended up being more of a phase 2 type of study. Wonder if they put too much on their plate, once the Heat trial was ended they put together a committee to search for other biotechs to buy out.
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