|
Junior Member
|
|
Join Date: Sep 2006
Posts: 9
|
|
|
Junior Member
Join Date: Sep 2006
Posts: 9
|
Commentary on the Results: Very Important!!!
The Results:
The trial did not demonstrate an appreciable difference between patients treated with CERE-120 versus those in the control group. Both groups showed an approximate 7 point improvement in the protocol-defined primary endpoint (Unified Parkinson's Disease Rating Scale- motor off score at 12 months), relative to a mean at baseline of approximately 39 points. Both groups had a substantial number of patients who demonstrated a meaningful clinical improvement from baseline. CERE-120 appeared to be safe and well tolerated.
Now I am awake (look out everyone!!!). After these results were announced, I was stunned. Ceregene is a very impressive company. They did an amazing job meeting the timelines promised and I have a tremendous amount of respect and gratitude for their desire to find an effective treatment so this is not a "sour grapes" comment. It is extremely important that everyone stop what they are doing, put their pencils down and hear this:
If Patient #1 in the real treatment group reduced their meds in a dramatic fashion and demonstrated a 7 point improvement and Patient #1 in the placebo group demonstrated the same 7 point improvement but increased their meds (which was permitted as long as the sponsor was notified in advance) how is this considered the same result? Please tell me the results were weighted in some way to account for this. If not, then a major injustice has occurred here!!!
Last edited by Tom819; 01-10-2009 at 10:34 AM.
|