Replies to post #389286 on NorthWest Biotherapeutics Inc (NWBO)

[anders2211]

Biogens aducanumab trial is a good example of, IMO and many others, ad hoc rephrasing trial endpoints aka the trial question. First, the trial question was (more or less) if aducanumab is improving the lives of the whole patient cohort (I think around 1500 patients). Then when the data was unblinded and analyzed they did not find any improvement in the lives of the cohort and dismissed the trial as failed. But then the Biogen department of statisticians by a miracle found that a small patient group with a certain type of genes are benefiting from aducanumab so now the question was changed post hoc data to "is aducanumab efficient for patients with these types of genes?" Answer yes is a miracle hallelujah.

Im paraphrasing here.

And also by some strange coincidence Biogen did not publish any scientific publication, more and more I admire NWBO for choosing the opposite and getting a publication done.

Im 90% convinced that aducanumab will NOT be approved by the EMA ..
By the way, the somewhat corrupt way that Biogen had aducanumab approved by the FDA will not improve the cooperation between the FDA and EMA IMO.

[hankmanhub]

Ultimately, NWBO set up a trial by defining those excluded and included to the trial, and to see whether the treatment (DCVAX) would improve (OS i.e., the 6 revised endpoints) now that after all has been said and done WHO comes along and reclassifies part of those included in the trial as non GBM should really have no bearing on the trial results. Think for a moment if the opposite were true and the "removal" from the trial caused the trial to FAIL, would you still be saying the same thing - that's how the cookie crumbles? Ie., if those redefined out of the trial were the cases that the treatment helped and could no longer count as a success leaving the narrowed trial to fail, after 15 years of effort, expense and trials just because the WHO came along in the last days and redefined GBM? No way, you would likely be arguing, WHO be damned, and our trial succeeded on those we intended to treat and should be approved by the FDA for all those included in the trial whether or not WHO changed the labels for those still very serious conditions that we now claim to have a treatment for. Well this is just the reverse of that, but the same logic still applies.

Ultimately, I still believe that the trial succeeded even without the new WHO definition of GBM, and has no need for this new crutch on which to posit success. Go NWBO.