Replies to post #534291 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

Conclusions
This phase 3, nonrandomized, externally controlled trial found
that the addition of DCVax-L to SOC was associated with a clinically
meaningful and statistically significant extension of overall
survival in both nGBM and rGBM. Treatment with DCVax-L
also had an excellent safety profile and noteworthy tails of long-term
survival curves.

[hoffmann6383]

LOLOL

I'll take the word of 73 relevant experts in the field that put their name and reputation on the line when publishing those results

have a great one Ex! by.

[hyperopia]

Apparently it was good enough for JAMA, ex. Sounds like you’re just looking for a shred of consolation. Something. Anything. Yeah, Northwest Bio cheated! And yet, somehow, it got past peer review in JAMA, for all the world to see. Boo hoo hoo

[thermo]

Ex, I've said previously that I thought the PFS endpoint failed, and it was at the core of the enrollment halt.

It's a subtle point but changing endpoints itself does not invalidate statistical conclusions. What matters is data dredging, which often is associated with changing endpoints but doesn't necessarily have to be. I got to think you, and other apparently smart people, understand that. So, I just don't get why you keep coming back to this point.

I've also said previously Stupp would support the trial and that we'd get a publication in a highly respected academic journal, like JAMA. I've also said that neurosurgeons not involved with the trial are very interested in the therapy (I gave one example, but I've had conversations with others).

A most important characteristic of the best investors is the ability to clearly judge new information, change your mind when the data conflicts with your prior (as I've also stated, I was short the stock once), and go big when it conforms.

Which way is the information trending in this case?

[sentiment_stocks]

Of course they used the MAIC adjustment. I told ici back in June in this post that they used MAIC:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169239751&txt2find=Maic

the DCVax-L external control arm instead used a “matching-adjusted indirect comparison” (MAIC) which comes very, very close to a one-to-one. So instead of matching the patients one-to-one, it matches by percentage each prognostic factor.

So yes, you missed that they indeed did use MAIC in the JAMA journal. You gotta look at that supplemental stuff. :)

Adjustment for Individual Patient Characteristics in ECPs
A fourth set of analyses was conducted to adjust for differences in the individual patient characteristics in the DCVax-L cohort vs. the ECPs. Propensity score matching could not be used because the ECP data were not accessible on a patient-by- patient basis, despite efforts to obtain such data. However, the percentages of specific patient characteristics were available for the ECP. Accordingly, we used Matching-Adjusted Indirect Comparison (MAIC) methodology (widely used in health economic analyses) to adjust for even small differences and re-assess survival outcomes6-8. This methodology applies a weight to each individual patient in the DCVax-L population in such a way that the sum of the weights for patients in each category for a characteristic achieves a match with the external control population. By way of example, if the external population included 50 males and 50 females and the DCVax-L population included 60 males and 40 females, the males would need to be down-weighted to achieve the required 50:50 balance. Applying a weight of 0.67 to each individual male and a weight of 1 to each individual female would achieve that balance, resulting in a new population with effectively 40 males and 40 females. When there are several characteristics to be matched (simultaneously), the mathematics by which the weights are applied to individual patients becomes more complex.
This matching was done on the characteristics of age, sex, race, MGMT methylation status, and KPS score, combined with one of either extent of resection or with residual disease. The MAIC weights required to adjust the DCVax-L cohort to match the characteristics of the external comparators were calculated in the statistical program ‘R’. These weights were checked to ensure that the characteristics of the re-weighted DCVax-L population matched those of the ECP, as well as for any outliers (particularly large weights) that could strongly influence the results of the analysis. Results between the unweighted and weighted (or matched) analyses were compared to confirm the results.

https://cdn.jamanetwork.com/ama/content_public/journal/oncology/0/coi220066supp2_prod_1668698380.82197.pdf?Expires=1671895142&Signature=M58ZRuoBIDiGCFvow2H28w5xOCYTjlat4nHXK~ojIcpb-4i~b4jPHm4f~iLZXS-0QksWPucZIRx4ik4S7YMUCblyvYJH0zz9KtKeAKhCZaPA-HZC-n1oX449Eh4~F1S1cUo1OmZGHK4DIRdcw2dVzfsA~-k~BWYtkXSniYVM4Hrin1vXDF2vb6hw-GZGpz2EpMdEX~M6qyvJoB2KuymczL-C-VyjN6PGLML5imVrliZlIgdW3fDzvq2Z-zcA0r90lJjan0fYzXWKgB0ArcrfXE6hi5brQvEGcIAxviRkGWFD~Wc1biOp~ppPdpLrgXoxoMsgMRpqOoxiI6jOJmRgvQ__&Key-Pair-Id=APKAIE5G5CRDK6RD3PGA

Hopefully you also noted the version number on the SAP was “1”.