OT
David,
Thanks for correcting me on dose issue. What I have in mind is total drug exposure per therapy cycle (yes, it is higher dose, mg/m^2).
Is dose 12mg/m^2/w, or total drug exposure for 4W is 48 mg/m^2?
Any idea why reduction in monthly regime?
Regards the Rubitecan, now I am neutral (if not negative).
From beginning problems was in drug formulation (stability, compound chemistry and fast conversion to metabolite), so they needed to solve issue on low availability, large variety in pts drug exposure, and correct dose/route (ng/ml?). I thought that they did solve some of those problems before going into three PIII trials. Unfortunately, found later that problems persist. Maybe I am wrong, but I think that they are now doing studies with new formulation. This will need to be done from start. IMO, results from ongoing trials will be at best ambiguous and far to support NDA. I do think that 9-NC is potent chamo, only one need to balance tox versus effect. Can they do it?
Miljenko |
