"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."
I disagree. American regulatory settings are based mostly on case law, so what you do with one case affects what you do with the next one...
"it is deceptive to equate a delay of approval due to CMC matters to one due to a requirement for efficacy data."
Yes but I think you keep missing the main point in this case ocyanblue. Mainly that the certain delay by the CMC issues may have given the naysayers the impetus to say "let us have more efficacy data since we have to wait for CMC anyway"... Moreover, since you refer to DSCO, note that DSCO was already delayed by two years on account of "minimal" CMC issues, so what makes you think DNDN is so different?
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