NorthWest Biotherapeutics Inc (NWBO)

[CogDiss 1188X]

Then there is the old chestnut about whether, if the primary endpoint fails, any analysis of secondary or tertiary endpoints gets relegated to fact-finding, but is not usable for approval purposes. Or is that myth (in this case)?

Must admit, this one mystifies me since I’m not up on the intricacies of clinical trial design and drug approval. If the above quote is true, then in oncology trials, doesn’t it makes sense to spend all your alpha like a drunken sailor on your first endpoint to increase the odds of approval? Onc’s aren’t going to look sideways at a decent PFS result since survival results are generally dismal. To continue the metaphor, any port in a storm. And if you believe your treatment may actually move the needle on OS, you may not get to claim it on the label but a sweet looking OS curve is not going to go unnoticed, in cancer or other areas.

I assume I’m missing something.