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Thanks dr Bala. Hope lykiri has the slides and would be good to see how LLs presentation is evolving.
Thanks Lykiri. Is there a link to LLs presentation from June 3? Sorry if I missed if someone posted it earlier. Appreciate it.
Gary - happy you get to go home. Wishing you continued recovery.
Makes sense Dr Bala. Thank you. I think FDA will have to follow the suit. I do think our fda would be the first one to approve. I won’t be surprised if they surprise us though.
What is ATL DC and Pembro combo trial at UCLA?
It’s a window of opportunity trial and they are looking for bio markers of response. It is not to compete with dcvax. It’s the same process and same product. So if anything it’s building on top of promising results (people seen living longer - not the much awaited phase 3 unblinded results)
Why do they need to find biomakers - well FDA bigwigs demand that for approval. So no bio marker no easy approval. Hence all the recent push at talks from LL.
Now let’s stop the debate of whether dcvax is efficacious or not. I only concede to debate around how to get this past RAs w/o bio markers. Maybe dr Bala and others can help me understand better.
Thx.
Amen and wish you a speedy recovery, Gary! Loved the optimism in your post!
Bravo, well said! I really don’t understand why there are so many of these on this board. It’s a Penny stock. Don’t understand the interest in shorting. Even if you do why spend so much time on this board… I guess we will never know since they are not going to let us in on the secret. Seriously you might as well research more stocks if that’s your thing. Or if you are lonely and want company just step out.
It’s natural to feel bad and blame oneself. But never ever give anybody personal information over the phone and internet especially money. I get so many fraud calls and texts which I myself can easily fall for.
Rule of thumb - always be suspicious of texts, calls and emails.
LOL. Keep it up my man.
Wow congratulations dr Bala and BB. I must say very impressive company on the board…
not everyone who needs this would be able to travel to UK or other places. So yeah fda matters.
Please do. Eager to learn more about your experience. And congrats.
No that’s not the impression I got. Maybe I am biased towards dcvax now. But when I hear her say anything like that she is saying don’t be nitpicking technicalities trying to satisfy the rules of ab testing as if you are trying see what would sell more toilet paper. Concurrent control vs external control etc. I
Let’s hope for the best that there are enough on her side of narrative to push this through fda. Maybe biden needs to stumble upon dcvax personally.
Thanks and I am not sure how much you all agree in noticing that each time she throws up these slides she becomes bolder in her claim. For example I notice she is talking more and more about FDA approvals and how every neurosurgeon needs to fight the battle of not giving placebo to anyone.
And I got a distinct hint that all these docs are convinced of DC results and are just getting their ducks in a row.
Dr. Bala absolutely yes. That YouTube video is marked private now. I had last 10 minutes remaining but what I heard for 50 min was really encouraging. Anybody who listened to last 10 min anything subtle you observed or heard?
I wonder why that video is marked private all of sudden ))
Wavelengthy thank you!!! This is what I needed to see - position of fda on ECA. I do believe gbm qualifies since it’s relatively well defined and high risk.
Thanks again for responding. Measured, well thought and data driven response.
Thanks ATL. Not debating whether results will be positive or not. I agree stupp protocol got through with very weaker evidence. But just thinking through the technicalities of decision making and pedantics in the field. Anyway, Was there anything published that I missed when you say following
Quote:
“
datafarer, the FDA and the other 3 regulatory authorities, in the UK, Germany and Canada, have already bought-into the use of external control arms (ECA)
“
Having had the opportunity to ask LL a few questions directly, I do think she is rallying support within the community and then to get FDA approve usage of external control. That’s how she is positioning all these talks. I do believe that it’s significant move and hint on her part. The slide from today’s presentation which talks about 3 different analyses was very interesting and shows the what all they are doing. I hope they hit stat sig on all the flows (although I think it’s stat sig just for a subgroup - but I want to be wrong)
The only question that’s bothering me is “if you so strongly believe in the results then why not rerun a proper p3 trial with support from top 5 institutes” Actually, this is a specific question from a Neuro oncologist who I tried to debate this with. I do not have a good answer for this.
I know some of you might say well release this as SOC and then keep on running parallel trials. I get that but with all yhe time that’s being wasted the trial might already be half way over by now.
Maybe dr Bala and others can chime in.
I wholeheartedly agree. No point in LL vs LP talk. I hope we are all pleased with the results Senti!!
Anyway I might hit 15 message limit so tacking this on - any word from LLs talk on trial update.
No harm no foul. After all you are talking about nwbo (mis)management here. Let us not drum up any deadlines next time around. We will know when we know.
Thank you dear ikeEsq! Best wishes!
Yes please Dr Bala. Thanks Nick119, I was about to post.
Thanks for constructive response and not running with nwbo train. I do think those modalities is what LL is trying to exploit further to find a cure.
Having talked to her I do get a strong sense that she isn’t too happy with LP either for mishandling her life’s work. Someday I would like to be a fly on the wall to heat the discussion of why she chose LP in the first place. But I guess I will never find that out and I’m ok with that as long as dcvax works out and cures people. Peace.
This is what’s at stake people beyond just the share price. Stop f*** around LP and get help to close the loop. Living in tomorrow doesn’t exactly work in the world of yesterday.
Yes totally logical. And perhaps trying to massage the data and message it better on why exactly it didn’t not work for everyone. Keep in mind they also have to defend against the argument - methylated group does better on its own. So I think they are churning through those results with added complexity of external control selection and yes the newb management.
One of the findings in recent years is that methylated group does better on its own. So I want to see the details of OS from the point of cross over.
I am not arguing that it doesn’t work. I don’t want to do that especially when there’s nothing out there. And know I am not making you feel good about your investment either. I don’t care about that honestly.
Anyway Now imagine this sort of doubt running in your mind as a patient making use of dcvax knowing that somebody knows the answer and won’t hurry up. That’s just criminal (sure not by the book)
Had a chance to listen to LP thru the recording of dr Bala. If I look at all the knot ration available, I think results are not stellar but there are subgroups who benefitted a lot. That’s what I think they think is not failure and didn’t announce that we failed. As far as I understood that 4 day rule or whatever, it’s subjective.
And for the love of god this management needs learn management. I get things are complicated and what not. They are destroying the product especially if the data isnt a complete home run (which I think it’s not for all subgroups) Well, they seemed to have learnt a lesson or two in recent months.
Please know that LL and LP are not optimizing for same outcome necessarily. I strongly believe there’s some dissonance there which is why the follow up trial doesn’t mention NWBO. I think it’s a way give the dcvax to people w/o mentioning its dcvax and avoid dealing with LP gang. Yes LL boosts confidence in putting money in nwbo. But don’t expect anything concrete from this management. We will get there when we get there.
It’s f*** difficult to keep calm if you are emotionally invested (long term holders and patients alike) And if LP thinks I am running compassionate use so not releasing data is not hurting anybody then no you are f*** wrong. Everybody would want make an informed decision by looking at data and not just your generosity. So nwbo folks hurry the f** up. Don’t give the world bs of covid and resources even after 9 months. I mean if god forbid you get this disease you’d not act this way. If you cannot drive this forward, let people who cam do so. Don’t be causality and Ask for help dudes!
For all those who are still reading - I choose to see the beauty in this world and hope these clowns are sitting on a once a century advancement. Amen.
Thank you as always Dr Bala.
Gary hope all is well with you. Sounded worrisome to see a neurosurgeon for neck procedure. It’s good to know that dr knows about her. She is probably the only thing right about nwbo and hope we don’t have to look for boosts in such qualitative signals. Peace.
Informative post, thank you!
That more at the end is where I think all of the confusion lies ??
Great discussion Gary and ATL. Agree with your reasoning if FDA approved stupp for all even if it benefited a sub group. I too hope they give significant updates on/before ASM. Just that their silence is frustrating and keeps an important resource away from patients.
Yes but need them to release that data first my friend. Any delay especially from hereon only points to the fact this is not a slam dunk per se. I hope I’m wrong though.
I know nothing about her to be biased. I am stating her name since she runs nwbo. But I see your point and would say nwbo gang instead of LP. I care only about getting data re potentially life saving vaccine.
Unfortunately as long as nwbo sits on the data, none of this would reach patients and benefit the longs. My 2 cents is that all the delay is because of teasing out the variance of sub group which does better. It’s less likely that dcvax benefitted everyone. Until data is released, nobody in professional community will bat an eyelid. Also, I think if data is successful, nwbo would have come out sooner. Having a positive data would only help expedite commercialization. But if LP is doing things to control more, then it’s distasteful. Let’s face it they cannot go at it alone. And for love of god release that data. Stop toying with patient care.
Congratulations Dr Bala!
Just for this, I pray that nwbo is a success. A cure cannot wait for legal and technical reasons. Please get in touch with UCLA and nwbo both and see where it takes you. I would like to believe they are not going to deny just because. After all, I believe they are good people. Fight like hell and pray like no tomorrow.
Ahp you have made an excellent point that some of us overlook. It’s not right to compare blinded data to soc directly. That’s why LL is talking about building matched control. Having said that I do believe dcvax will likely show improvement even those settings - hope that’s still in the double digit benefit % over soc.
Good on you my man. Stick to your guns. I hope they have good reason for this delay after a positive news. God bless us all.
So no dcvax phase 3 trial update then??