Friday, September 09, 2016 5:40:52 PM
In thinking about SPPIs situation, having apaziquone only effective for NMIBC was a godsend. Qapzola needs the hypoxic environment of the bladder to be converted into an effective drug. As we know you can't inject it IV or PO or IM because it will break down. It is only effective if instilled in the bladder, no place else (period). Because of that SPPI could only run one type of trial and that was to instill apaz into the bladder. Not many variations to that. It's not like you ran the trials in various type of cancers to see which cancers it would be most effective. If that was the case you wouldn't be able to combine them since the trials most likey wouldn't be that similar. And because of that, the 2 P3 multi-center randomized placebo controlled studies were almost identical to the last detail. And because of that, combining the 2 studies was not much of a stretch so instead of 570ish patients in 2 studies you combine 1146 pts from the target population to treat as one set. No different than having 1 study with 1146 pts. You'd get almost the same exact results. Ok, nuff said till Wed (I think).
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