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exwannabe

01/31/23 12:34 PM

#563656 RE: Tartiaboy #563600

I forget where I have seen you, but whatever. Here is my take on some of these points.

First, on shares, they already have about 1.55B on a fully diluted basis.

Second, on the PFS issue. I will agree that if PFS vs OS was the issue, NWBO might have a decent chance with this trial in front of the FDA.

Problem is, OS in the randomized trial came in very bad. Likely trending worse for the treatment group than those randomized to placebo. Yes, crossover would be expected to close the gap, but nobody would expect it to eliminate it. Even if using DC post progression was just as effective, you would still expect treatment arm to live longer as not everybody crossed over.

We cannot discuss the actual 232 vs 99 randomized OS numbers because NWBO elects not to disclose them. The trial reached the original predefined stopping point early 2017. It reached the number of events for the OS analysis in late 2017.

Going for a long tail, NWBO elected to allow the trial to run until 2018 when they declared it was sufficiently mature to evaluate it.

So sometime in this process (despite at least 1 efficacy IA being performed) they realized they should switch to external controls. Alas the controls are questionably matched.

As far as the FDA, NWBO has not even disclosed plans to submit to them.

EDIT: I see it is SPPI I know you from. I was in and out (long) for several years. Stopped playing years ago thouigh.
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antihama

01/31/23 2:01 PM

#563697 RE: Tartiaboy #563600

I realized that I mentioned the problems of the P3 trial but I didn't discuss the outcome. They revised the endpoints to measure against external controls since the original endpoints were confounded. The trial was discussed in a prestigious JAMA Oncology article that came out 2 months ago. Here's NWBO's PR highlighting it and the JAMA article is linked within which you should read.

Northwest Biotherapeutics Reports Positive Top-Line Results From Phase 3 Trial of DCVax®-L for Glioblastoma
https://www.prnewswire.com/news-releases/northwest-biotherapeutics-reports-positive-top-line-results-from-phase-3-trial-of-dcvax-l-for-glioblastoma-301681901.html

And check post 543420 for a transcription of an interview of the lead author, and one of the top oncologist surgeons in the world, discussing it.

Do you believe that NWBO can sort out the psPD and mixed OS data to the satisfaction of the FDA or is there pushback?

So yeah, I do. The endpoints were accepted by the EMA and MHRA. Check out the links in a post posted yesterday, 563236, discussing that. Even Dr Pazdur, head of CDER, not to long ago was a signatory of a paper discussing external controls titled External control arms in oncology: current use and future directions

https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext#%20

I'm heading out now and will be on an all day hike tomorrow but if you're interested this will keep you busy

PS I can see that a lot of posts are being generated from your inquiry which is typical of this board. Very dynamic and a lot of excellent longs on the site.