Replies to post #5668 on Dendreon Corp fka DNDNQ

[rancherho]

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If DNDN loses its Motion to Dismiss and discovery commences in the class action lawsuit, many unpleasant facts may come out. IMO, the probability that croumagnon's belief that the failure of the FDA preapproval inspection and the FDA's assessment of the time that DNDN would require to correct the problems was a major factor in not accepting the Advisory Committee's recommendation for conditional approval and was a major factor in the FDA asking for more Provenge efficacy data from the ongoing IMPACT trial. If DNDN wins its motion, we'll prbably never know whether or not this was true. OTOH, if it is true and the manufacturing issues were serious and hidden from shareholders (as they continue to be), wouldn't you agree that this is something that shareholders deserve to know?

[DewDiligence]

>Suppose that the FDA did not believe that there was sufficient evidence that Provenge works, then it was clear that new efficacy data should be required. The CMC issue would have had nothing to do with it. This decision would be a rational one.
Now, suppose that they actually believed that there were substantial evidence that Provenge works as the vote of the AC showed. But because of a CMC issue that could be resolved in a few months or a year and because "additional efficacy data is always a good thing", human nature then let them require new efficacy that at the time was estimated not to be seen for 3 years. That's at least a couple of years to three years of waiting while people are dying.<

This shows an astonishingly lack of shading on your part—you’ve overlooked the scenario in which the FDA’s decision to approval or reject Provenge fell right on the cusp. In such as case, is it perverse to think that a “side issue” such as an unresolved CMC issue could have tipped the balance?

>Given that [FDA] always had the ability to withdraw approval on new negative evidence, this decision would be not just irrational but also inhumane.<

This canard is often repeated by Dendreonites. In fact, the FDA does not rescind marketing authorization due to a subsequent showing of poor efficacy for drugs that were originally granted full-fledged (non-accelerated) approval. That the FDA could legally do so is irrelevant inasmuch as this is viewed by the Agency as a “nuclear” option.

Score: rancherho 1, crougmagnon 1, ocyan 0