Friday, June 05, 2009 8:30:19 AM
I believe that might be called "circling the wagons." What could possibly be the reason to bring all of these folks together except that their clinical trials are failing.
When has this type of move ever been seen before in a successful drug candidate? This is more typical of a failed drug.
The use of the term “encouraging” from a Proellex clinical investigator has to be problematic. Isn't efficacy a slam dunk? Also. “should help” is not a measure of confidence.
It will be important to exclude any and all potential "conflicts of interest." From past RPRX dealings, they will need to be careful about their data collection [Vasomax].
What will this group of individuals change in the trial design? Any change will necessitate the phase 3 clinical trials to be repeated! And what would be the possible change in efficacy, if any?
All of this points to significant SAFETY problems and concerns.
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