wrt stopping at 98 deaths in the TAX 327 docetaxel trial yielding a calculated p value of 0.20, IMO, that statement would have stopped Hussein and Scher cold at the Advisory Committee meeting,
This type of retrospective statement about a different trial is good for an exploratory discussion but it would unlikely to go over well in a regulatory setting.
the failed February preapproval manufacturing inspection would ultimately have produced the same result.
If by "same result" you mean a delay of approval, perhaps. But, IMHO, it is deceptive to equate a delay of approval due to CMC matters to one due to a requirement for efficacy data. The former is fixable - heck even DSCO manufacturing issues seem to be getting resolved, while the latter could be for good. Put it another way, if CMC was the issue, DNDN would do well, but as it is, if IMPACT fails, DNDN will likely cease to exist.
