Replies to post #617694 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

The ECA endpoint change was not "vetted" by the FDA. As a change to the trial protocol the FDA allowed it as being safe and ethical for patients, The change was made after NWBO knew of the futility rec on the original endpoints. And that is that.

Regardless of that the RAs do not play by the same rules as the sponsor does. They most certainly do look for possible sources of bias. And with an ECA they will certainly look for differences in the populations that can explain the results.,

Back to the thread, the post I replied to was asserting that regardless of formal stat issues the evidence is obvious. I replied that is fr from clear. when one understands the resection extent issue.

Anybody (LL even stated it) would assume that -L had the most benefit with near total resection while not being as effective with a larger remaining tumor as the immune system is good at killing a few cells but not as effective against a large mass. Yet, the trial results supposedly showed otherwise. They saw no benefit over ECAs where it was expected to (and where it was more apples to apples) and large benefit where it was nit expected (and the populations differed.

Consider this. I run a trial to show that Nike shoes make you run faster, I recruit high school kids intending to try out for track and field. I compare that ti an ECA of high school kids. Of course Nike kids shows a benefit, but drill down a bit. In the kids that made the track teams Mike shows no benefit but in kids not on the track team the Nikes smoked. Why? Because the kids intending to try out would be faster than the couch potatoes.

Exact same issue here. The intent for near total resection shows up as a "win" for -L in the group w/o near total resection because they would have less remaining tumor than those in the ECA where the tumor was mostly or totally inoperable.

There are also other serious quirks. Most would assume that if -L works then it would help to use it prior to progression, Yet, if the results are vlid, the entire benefit was the use of -L after progression. The 99 lived as long as longer as the 232, and that is a fact.