Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
awesome- even if some here consider her "statistically dead" (whatever that means).
I bet she and her family feel quite different. :)
very intriguing- I don't really understand the mechanism underpinning this timing pattern but I'm interested.
Interesting take, since at least one big pharma has their premier I/O agent in combo with DCVAX at UCLA currently. :)
Considering the helmet got approved in rGBM off a trial showing no improvement in survival, this has a very good chance of approval-- particularly in light of the multiple trials showing an OS benefit and an amazing safety profile.
hopefully the clog has been cleared, so to speak.
Awesome Lykiri, thank you. I guess the data have matured to at least 820-850 days by now- I would love to see an update this spring.
For the rGBM data with pembro (55% survival etc)- does anyone know (approximately) when Liau first showed that graph with about 700+ days reached? I would like to estimate how far out that trial is now based on the month that it was first revealed.
Thank you! :)
yep, and ~55% rGBM survival more than 700 (800?) days from a current UCLA trial as well- lots of data with beating hearts for the OS-focused regulators to digest. I'm just happy for those patients and their loved ones. :)
A good test of this idea might be to see if any company participating in the specials program has ever released such data prior to review by the MHRA or appropriate authority. I doubt it, frankly. :)
I believe the data from the UK specials program is earmarked for review by their own auditors/ reviewers, I would be very surprised if the company were allowed to share patient data prior to that review (and possibly even after).
Overall, a pretty silly narrative. :)
I don't know if the specials program allows that to be disclosed publicly as it isn't part of a trial- others here probably know. :)
And the confirmation is already there in JAMA oncology as well as the other combo data from Liau et al. :)
False. See especially the Liau data in rGBM combo'd with a checkpoint inhibitor- 55% survival out past 700 days. More great results in the ICLC combo as well. I'm glad we are both happy for those survivors and their families. :)
an example of no benefit over SOC would be the Optune EF-11 trial- check it out. :)
fortunately there are fewer dead GBM patients now thanks to the OS benefit in several trials using DCVAX-L, as well as the specials program. I'm glad we can agree that this a great thing for patients and their families!
please don't alter my posts :)
agreed, but not as weird as them submitting and getting approval for PIP if they didn't know it was required (as was claimed). Guess they were just bored. :)
Weird that they applied for and got approval for PIP design then. hmmmm...
I don't trust many people in general. I prefer data. :)
I do? Where?
Where did I deny anything happened? Getting strange around here.
Anyone who cares about patient outcomes, I would think. :)
yep- oncologists have learned a lot about psuedoprogression, the limits of PFS predictive power, etc since then. Much like you I'm just glad that the OS benefit is stellar and that patients are living longer in multiple trials with DCVAX-L, despite the inadequacy of PFS as an endpoint-. :)
Yes- but Optune isn't available and/ or reimbursed everywhere due to lack of convincing efficacy and outlandish cost, so it would depend where he (or the theoretical patient) lived. I respect his opinion though. :)
Interestingly the helmet with no OS benefit was approved in rGBM (EF11 trial); seems like that bodes well for the massive OS benefit seen with DCVAX with no side effects and systemic activity.
PFS was a great idea, but unfortunately it isn't always (or even often) a good surrogate predictor of survival benefit. Immunotherapy has further complicated this due to pseudoprogression and later responses, etc. Seems many governmental bodies/ regulators want to see beating hearts these days.
no quote then? Ok I'll add this to the list. :)
Can you link to that quote from Linda re: coffee?
I didn't see where he said critique of lack of communication and transparency was bad- can you highlight that part? :)
Correct- in response to someone else bringing them up. :) I was mistaken on the timing though.
It's not my straw- I didn't bring them into the conversation. You seem rather obsessed with CVM but I really don't know or care much about them. :)
Someone did tell me that DNDN took longer, but I don't know if that's correct.
Ok- that's at odds with a claim that was made yesterday. Thank you! :)
Sigh. I think the trial was a resounding success. Please stop intentionally misrepresenting my position. :)
This was your original challenge:
"please provide me the name of a biotech that has taken longer than 2.5 years to submit a request for approval after datalock"
Notice that a successful trial was not specified. Thus, the goalposts have now moved :)
Guess I'll keep waiting for that list- it's almost as though it never existed.
Oh, then the goalposts are moving. Unsurprising. :)
I also never compared NWBO and CVM, nor did I say that NWBO's trial failed. In fact, I pointed out why comparing the two is rather silly. :)
where is the list of longs who have given up on approval?
I wouldn't expect a clear explanation of any individual patient's journey, they don't owe anyone that.
thank you- seems that saying she "chose" not to get DCVAX is a gross oversimplification and possibly wholly untrue. I wonder what would motivate someone to do that.
very illuminating. Sad that some would try to use such a situation this way.
invoking her illness to attack a company with a successful treatment for GBM is pretty distasteful. Soul staining, even.
I'm not sure the patients would care about % revenue. :)
I can only speak for myself but I don't expect posts to move the share price. :)