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Rubyred77

12/01/17 2:23 AM

#132488 RE: Rubyred77 #132484

Cancer is the reference, but it should also apply for other diseases as well.

What do we do when we have a targeted drug, introduced in a properly selected group of patients, which has an outsized effect on overall survival in a rare or deadly cancer, but where that benefit is seen in a small trial, where we would still need more evidence to fully understand how to best use the drug in clinical practice?

We might want to approve such a product earlier, and require a post-market confirmatory study to validate the finding – similar to an accelerated approval approach.

attilathehunt

12/01/17 7:59 AM

#132501 RE: Rubyred77 #132484

No. I saw it and mentioned that perhaps part of the perceived delay is due to AA fro AD in Aussie land. Wouldn't that be a shocker!