NorthWest Biotherapeutics Inc (NWBO)

[dstock07734]

meirluc,

Great point.

First, I suspect that the data from the p3 trial after the data lock can be shown to the BPs as long as there is NDA involved.

Second, assuming that the data from the p3 trial is available to BPs only after May 10, 2022, would LP have some other data that can convince BPs on the efficacy of DCVax-L? Absolutely. Let me elaborate on the reason.

We have seen the extraordinary outcome measures adopted for the combo trial which started in 12/2019 and without doubt the trial design must have UCLA, Merck, NCI, and NWBO involved. The reason I say it is extraordinary is that I cannot see any other trials listed on clinicaltrials.gov having some measures like this. What could make them so bold to adopt such radical measures? They must have seen data related to these measures before they decided to adopt them as outcome measures for the combo trial. Now we have seen the t-cell expansion from the p3 trial as shown below. But we assume that all the data related to the p3 trial including the t-cell expansion was not available before 5/10/2022. Can we assume that the data related to the outcome measure in the combo trial has been collected from the UK Specials program which used DCVax-L + SOC before 2016 and DCVax-L + Poly-iclc after 2016, the poly-iclc trial, the secret collaboration trial on colorectal between Merck and NWBO, the expanded access program which was involved over 100 patients not eligible for the p3 trial? Certainly.

So even without the data from the p3 trial, NWBO still had tons of data on the efficacy of DCVax-L to dazzle Merck or any potential partner.





This is the slide on patient #5 in the combo trial from Dr. Liau's presentation. The immune response was so intense that the patient had to go through surgery to take care of the inflammation tissue and later was administered immune-suppressive medicine to suppress immune response. We already marvel at the t cell expansion from the p3 trial in which we can see that the number of t cells can reach 1700 while the base line can be 20. I believe if there was immune response as intense as the one in the combo trial and patients had to go through surgery, it must be reported as severe adverse events in the JAMA paper. I don't recall seeing such severe event in the JAMA paper. Can you imagine how big is the umber of t cell expansion after including keytruda? Maybe 17000. I remember the last patient for the combo trial was enrolled at the beginning of June of 2021. I firmly believe by the time Merck decided to start the construction Merch had seen enough data from the combo trial too.