Biotech Values

[jq1234]

I figure it's worth pointing out to readers that ONXX appears to be following the path that MLNM did for Velcade. Try to get approval through a single agent trial and have a controlled trial in an earlier setting underway to satisfy the accelerated approval requirements.

This was what most oncology agents had been done with accelerated approval. However, accelerated approval landscape in oncology has changed a little bit especially with Avastin situation in MBC. Roche now is arguing that the confirmatory studies that failed to show survival benefit in MBC were different from the study that granted Avastin accelerated approval because it used different combination with Avastin, thus Roche should have the opportunity to conduct confirmatory study in the same combination as the study granted accelerated approval. Avastin in MBC situation will have great impact on how accelerated approval is going to be in the future.