NorthWest Biotherapeutics Inc (NWBO)

[gpb]

After Pazdur did a lot of that crap he finally got smacked down pretty hard by Hamburg, Woodcock, and the GC, then sort-of reassigned (but is still an important figure). That's part of how arena managed to get lorcaserin past the second adcom. Anyway, as much as I dislike this man, if you want to read a document where even he effectively recommends strong PFS as a surrogate for OS in randomized trials, use this one:
http://www.fda.gov/downloads/drugs/developmentapprovalprocess/developmentresources/cancerdrugs/ucm094735.pdf

My favorite part starts on page 23 when they recap the FDA policy questions:
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1.1. What if any non-survival endpoints reflect or predict clinical benefit?
The panel agreed that 6-month progression-free survival (PFS) (with clinical stability as currently defined and without the use of local therapies) is a meaningful endpoint.
1.2. What if any endpoints available now may be reasonably likely to predict clinical benefit?
Dr. Pazdur said the term reasonably likely refers to surrogate endpoints that are “reasonably likely to predict clinical benefit,” the standard for granting accelerated approval (AA).
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So 6-month PFS advantage is a predictor of clinical benefit, and predictors of clinical benefit may be used for granting accelerated approval. Even for Pazdur.