Tuesday, May 24, 2016 11:15:54 AM
As Turney pointed out, the FDA does have rules and guidelines (and benchmarks) that generally have to be met before even preliminary results can be released without the company doing the work getting into trouble.
My guess - not enough milestones or benchmarks have been met to get permission, or for CVM to request getting permission to do so. Possibly the results are not obvious as yet,...
The other possibility is that just not enough of the test populations have gone deep enough into the post-treatment phases of the study to get a sizable pool of patients with data to evaluate.
Also true,...
But keep in mind that due to the FUBAR that InVentiv presided over through the early part of 2014,... there is almost no portion of the people who have been treated who have reached the primary endpoint measurement date.
The 100-odd patients that InVentiv enrolled prior to 2014, and who would be reaching or that had past the 3-year survivorship primary endpoint mostly cannot be counted (according to CVM that is),.... pull them out of the data set,.... and there is essentially no set of individuals that have useful data yet.
Sad but true. And one of the reasons that CVM might just have a case against InVentiv,.... if they can ever get it moved forward in the court docket.
Ergomed enrolled about 70 or so patients in 2014. Those 70 patients will have completed their 3-year post-treatment period during 2017.
Ergomed enrolled about 340 patients during 2015. Those 340 patients will have completed their 3-year post-treatment period during 2018.
Anybody that Ergomed has enrolled during 2016 (~135 so far) won't have completed their 3-year post-treatment period until sometime in 2019.
Even IF CVM is getting solid and promising data to date, and IF CVM were inclined to try and get permission to get some of that out,.... there just isn't enough data there yet (IMO) to merit their doing so.
“The two most powerful warriors are patience and time.”
- Leo Nikolaevich Tolstoy
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