RE: RE: RE: RE: RE: inrollment numbershey buddy. im not a pumper of ctic. Yes am a shareholder i would love for it to as high as it could...,i was just stating that the FDA did not like the fact that the enrollment #s of ctic were less than they wanted...the same problem SSS has... thats all im saying .....and the if the FDA says @#$% you @#$% .thats the bottom line ...
The FDA had a lot more problems with ctic than just enrollment numbers...
In particular, the FDA felt that:
"Pixantrone has demonstrated evidence of biologic activity, but the mere demonstration of biologic activity is not sufficient for approval."
the FDA also had concerns regarding:
- Neutropenia and infections were higher in pixantrone than the control
- Cardiac toxicity was higher in pixantrone than control, including heart failure and ejection fraction
As highlighted in the original analysis of the pixantrone filing, the FDA were also unhappy about the shortened study given only 140 people were enrolled out of the planned 320, leading them to conclude:
- Study was not well executed or complete.
- Study was inconsistent (only 8 people enrolled in the US and none had a complete response).
- Trial did not demonstrate statistical significance or robust findings.