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croumagnon

04/12/08 8:21 PM

#5665 RE: ocyanblue #5659

..."then there really isn't much for us to discuss. Believe what you will"

You are beginning to sound very much like Dew after he loses an argunment...LOL...

The point I was making is NOT that efficacy is the same as CMC issues even though you used my words selectively to make it seem as such. The point I was making is, and I repeat the FULL sentence from my previous post:

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?

So what is it that you disagree with? The fact that the CMC problems did not affect the efficacy decision of the FDA? I disagree with you because human nature says that one decision affects another in these games. If the FDA was convinced that the CMC issues were going to cause a delay of a year or so, then it is easy to see why they would require further efficacy data as well since they would not at that stage feel guilty on account of delaying the treatment from patients, and additional efficacy data is always a good thing...