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Re: Spideyboy post# 12210

Wednesday, 11/15/2017 5:42:53 PM

Wednesday, November 15, 2017 5:42:53 PM

Post# of 43830
This is my understanding of the point Spideyboy:

Also while I see this 3 year time-frame being mentioned, then why has it been stated that Cel-Sci needs to reach 298 events to determine if the primary endpoint is met or not?


The experiment was designed with old numbers (expected survival rates) on what the company should expect. This is a flaw in the design that many of 'us' here have talked about and argued about over the years.

Since the mortality rate numbers for these cancers (based mostly on demographics from before 1990) are lower now than back then, they anticipated that 298 people in the study would die within that survey period.

Because treatment and diagnosis (in general) have also improved, the numbers that the experimental design was based on didn't work as well as expected for Cel-Sci's Phase III.

Because patients (both control and treated) are surviving better and longer now,... it's harder to reach 298 patient deaths within the anticipated period.

If the mortality rates today were as high as they were 20-30 years ago, they would have expected to hit 298 patient deaths sooner.

“The two most powerful warriors are patience and time.”
- Leo Nikolaevich Tolstoy

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