Saturday, May 17, 2008 2:13:08 AM
Analyzing the safety of CX717
If they chose to go low, that could be interpreted that yes 900 and/or 1500 demonstrated efficacy but demonstrated side-effects so the lowest effective and safe dose would have to be found.
Chosing to go high, if a decision made based on 900+1500 data it would most likely have to be to see if CX 717 would also be safe at a much higher dosage. If it was done due to nonsignificant effect at 900 and 1500 then I will need to quench my thirst,, at least until something good finally, hopefully happens.
I would lean towards the side that the people who designed this trial have a "good" appreciation of CX717, its pharmacodynamics and kinetics, and target cells to be aware that if efficacy would be achieved, 900-1500 would be well within the expected effective range. That appreciation would include the full trials to date data including information that likely has not been published. No matter how intelligent outsiders looking in are, if outsiders don't have access to all pertinent data the assumptions made have greater chance for error.
There must be well thoughout analysis and awareness behind the decision for RD1 dosage to be what it is.
Scientists for the most part are scientists in and out, I'll leave it at that.
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