Replies to post #209840 on 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.

[sentiment_stocks]

I'm still trying to locate in time the Doc Bosch comment about the pseudo-progression issue wreaking havoc in immunotherapy trials in general. Maybe it was the ITOC meeting in Germany (March 2015)

No it was in a live meeting on which he served as the chair of a panel. Many of us listened to it (it was not videotaped), but it was never subsequently recorded or videotaped and posted somewhere. It was a panel held in London for some event... and I think it was around April 2015.

[Lykiri]

After that, I recall that LP said in a PR something to the effect of 'we will be doing an efficacy analysis later in the year' but for the life of me, I can't find that reference now.

May 7 - 2015 Linda Powers:

In terms of the interim analysis, it would be likely to be this year, potentially in the coming months." Minutes 26'10 of the VirtualInvestorConference Webcast.

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