Agree. This trial has (at least) two concerns: (1) the dependability and interpretation of the PFS endpoint, and (2) cross-over post progression, which imbalances the control/treatment arms.
PFS endpoints in immunotherapy trials are not as dependable (meaning correlated with OS) as those in more traditional trials, and this is becoming more apparent as the body of completed immunotherapy trials increases. This problem can occur when lymphocytic infiltration results in tumor inflammation (which looks like progression) or (since immune activation is a complex process and often operates with a delay not seen with cytotoxic agents) when new lesions occur prior to the delayed immunotherapy response. See https://academic.oup.com/annonc/article-lookup/doi/10.1093/annonc/mdq048, http://clincancerres.aacrjournals.org/content/15/23/7412.long
So, I don’t think one can be certain of either success of failure with the NW Ph3, but given the market cap, I think it is a screamer. In my investment career, I’ve only had one certainty (see below), but this one is a bit more exciting than most.
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(1) except for one interesting case where the market was pricing a merger ratio that (a) differed from what a company press release indicated and (b) the CFO then confirmed to me that the press release was correct. It was a micro-cap and I bought all I could before over about 30 minutes before the market corrected to the data in the press release.
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