Anegative opinion for the approval, and a negative opinion for the "product", as which you stated in your post are two different animals. As far from what I read the negative opinion for approval was due to provide further trial and analysis before it becomes favorable. As far as negative approval for the "product", I see no inference to that in the article.
In a disease state there are flucuating sirvivial rates. This impacts how a study or trial is interpereted. So if a mortality rate of a certain type of cancer is 10-16% and in a small sample population the survival rate after taking Genasense seems to move the mortality rate down towards 8-12%, there is some crossover between the disease and the treatment(in this case Genasense). So the FDA was asking for a bigger sample size to prove the efficiacy of the drug. I made a post a long while ago saying that this was the information that the FDA wanted and is still deciding on. This was how i interperated the article. I will look for the article again and post it. As always though tdo you own DD.
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