Lars wrote:Stunning results with the worst group makes for a stunning future. Backfire. Their opinion is that Tovaxin still has a future with mildly affected patients but NOT with advanced cases.
That is an interesting interpretation and one that could easily be flipped 180° with the interpretation that Tovaxin working great for more affected cases. A 0.2 ARR for more seriously affected cases should be considered very good especially compared to other approved treatments. As an aside, many thought that the Tysabri results were fishy because many thought that the Tysabri arm was much less affected than the placebo arm.
It seems that the general problem with reaction to the top line results was that the placebo group was too low compared to the Tovaxin group giving the impression that Tovaxin didn't help out all that much. However if the two groups were indeed very different, non-randomized populations then direct comparisons are statistically invalid and meaningless.