NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Flipper44,

On December 15, 2016, i believe doctor Linda Liau publicly announced that ending the DCVAX-L trial was absolutely no option and she had a good reason for this decision. The attentive listener was then aware that the trial would continue for a while!

I agree that it is an unorthodox approach to publicly announce a recommendation but I agree with Doc Logic that the playing field is often handicapped!

Quote Linda Liau:

“i guess one example of this is for instance we have a DCVAX clinical trial and which was designed several years ago and as part of the design we included a crossover arm because we felt that it was not necessarily fair to have patients randomized to treatment and and placebo and then not allow the placebo patients to at some point you know to get the vaccine ehm but but you know the at the end of the day what’s happenening is that the entire group is doing better at least you know it’s not unblinded yet i don’t know that where the groups live but both groups are doing better and it’s probably because the crossover arm those patients that got the DCVAX-L vaccine also saw some benefit so it’s it’s i personally think it’s great for patients that that both groups on on the clinical trial are doing better but unfortunately if the two groups don’t seperate in terms of how they’re doing we don’t get these drugs FDA approved and that’s that’s always a struggle you know you want to have the purest data is to get that placebo arm and prove it with definitive i guess evidence that something works but it’s really hard to withdraw you know with with old treatments from patients but when we try to combine the two unfortunately the i think that the regulatory don’t regulatory agents don’t necessarily understand that.”

Source: LIVE Q&A - Brain Tumor Treatments & Advancements
Seattle Science Foundation 24 Jan. 2017(published)

We were LIVE on Facebook with Charles Cobbs, MD, Director of the Ben and Catherine Ivy Center for Advanced Brain Tumor Treatment and Linda Liau, MD, Director, Brain Tumor Program, UCLA School of Medicine taking all of your questions about brain tumor treatments & advancements.

Min 22.54-27.42 :

Linda Liau:
“Yeah we are fortunate that we have a comprehensive brain tumour program and you know and at the end of the day i think you know for all of us the patients do come first.and they they they do you know they we always want to do what’s in the best interest of the patient not necessarily the data and and you know we had this conversation this morning euh unfortunatily in doing that it you know because of the strict regulatory guidelines you know from the FDA it may hamper our ability to get some of these drugs FDA approved and i wish the regulatory agencies kind of understood this better and i guess one example of this is for instance we have a DCVAX clinical trial and which was designed several years ago and as part of the design we included a crossover arm because we felt that it was not necessarily fair to have patients randomized to treatment and and placebo and then not allow the placebo patients to at some point you know to get the vaccine ehm but but you know the at the end of the day what’s happenening is that the entire group is doing better at least you know it’s not unblinded yet i don’t know that where the groups live but both groups are doing better and it’s probably because the crossover arm those patients that got the DCVAX-L vaccine also saw some benefit so it’s it’s i personally think it’s great for patients that that both groups on on the clinical trial are doing better but unfortunately if the two groups don’t seperate in terms of how they’re doing we don’t get these drugs FDA approved and that’s that’s always a struggle you know you want to have the purest data is to get that placebo arm and prove it with definitive i guess evidence that something works but it’s really hard to withdraw you know with with old treatments from patients but when we try to combine the two unfortunately the i think that the regulatory don’t regulatory agents don’t necessarily understand that.”
Dr. Charles Cobbs ………..
Dr. Linda Liau:
“Yeah i think it would be good if we could ehm think about what the comparators could be short of a ramdonized placebo-controlled clinical trial if it could be you know strict ehm contemporary or historical controls that we could compare the treatments to i i do think that the sience needs to be there you know treatments can’t just be given that that don’t really have have a benefit because that’s you know not not good for the healthcare system and not necessarily good for patients but but i think there are treatments that that we may not be able to get the patients because very few patients would want on a placebo arm that’s” (Dr. Cobbs) “just the way it is in the United States they’re not patients are not going to say okay i’ll join i’ll i’ll sign up for the clinical trial knowing that there’s a 50/50 chance that i may have no access to this potential breakthrough so those are the issues we’re dealing with which are totally understandable.”