NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

[quoteI would much prefer the Journal first, and things taking their planned course, but I can't help but thinking, what if?][/quote]

I am sure that many of us are disappointed that we have yet to see the publication.
DRCS (post 498917) states that the peer reviewers found some problems with the publication that seem not to be easily resolved. DCRS may have some credibility and information that most of us don't have, because he (or she) posted a few days before the data lock that DL will happen within a few days. I have no idea how this poster received the information.

The only difficulty that I can envision for the publication is that about 33 patients who never received L and who were therefore separate from the Treatment and crossover groups, most probably had the worst outcome in the trial and their separation from those two group may have inadvertently left the better survivors in both the Treatment and the crossover group. In other words, 90% of the patients (about 296) were well enough to receive L early or after progressing whereas most of the 33 left probably included many patients who were very sick, as well as some relatively healthy patients who did not receive L for a variety of reasons and perhaps a few patients who never progressed.

The early as well as late L recipients may therefore not be completely comparable to the external controls because the external control trials had the disadvantage of retaining all patients including those who were in poor shape and would not have been eligible to be treated with L.

Don't get me wrong. I still believe that L is extremely efficacious. For example, of the 33 never L treated patients, we may have 5 who never progressed, 5 who were in reasonable shape but for reasons unknown to us never received L and 23 who were very sick and received salvage treatment. Had those 33 remained in the Treatment or crossover group they may have decreased the OS of those groups somewhat but no where near enough to torpedo L's efficacy.

I don't know if this is one of the problems inherent in the publication but if it is, I hope that the authors with the help of statisticians can find the appropriate answers.