So if I read their strategy right, I suspect it goes something like this:
Run 306, and if it has home-run results, take it to the FDA for approval. If the results truly are spectacular and are backed up by bone scans, then an AC and the FDA will have a hard time saying no.
If 306 results are good but not spectacular, wait for 307 results and take the combined package to the FDA. Meantime, the drug might actually be approved for MTC by then, and maybe they get some off-label use in prostate anyhow.
There is a read here that what they are doing speaks of confidence in their drug - either that, or desperation. Does seem like they either completely misread the FDA or got blindsided - most likely the latter with the FDA posture changing after their committee meeting.
We should get some more data shortly at EORTC.
Peter
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