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Re: dennisdave post# 524628

Tuesday, 10/25/2022 11:47:55 AM

Tuesday, October 25, 2022 11:47:55 AM

Post# of 821990

the simple answer is Liau never said this:


The part attributed to LL is that NWBO does not have patient level data. It is a fact that they do not. I have no idea if and when LL said it.

It is a fact that Medicenna used patient level data for their P2, and for the P3
See this paper

Using propensity score weighting, we compared rGBM patients from the Phase 2b trial (NCT02858895) (2017-2019) to patients from rGBM registries who had received standard of care therapies (2011-2019) and met eligibility requirements. Propensity scores were estimated using a logistic regression model with 11 covariates. We compared the propensity score weighted groups according to demographic and disease attributes before and after weighting and compared overall survival between the two groups.


In advance of a Phase 3 trial, comparison of Phase 2b trial results to an ECA suggests that MDNA55 may be efficacious in rGBM. In view of the known challenges associated with drug development for rGBM, these results provided a proof-of-concept for the design of a novel hybrid Phase 3 trial. This planned Phase 3 trial incorporates propensity score weighting to create a composite hybrid randomized and external control arm, an approach preferred by the FDA over full replacement of a randomized control with an external control.


Note: propensity scoring requires patient level data.
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