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Started By
Message
Northwest Biotherapeutics (NWBO) - DCVAX-L Trial
Posted on 5/4/22 at 11:40 am
Posted on 5/4/22 at 11:40 am
Alright, last two threads on this one got anchored so I'm trying this again. Not going to retype all the DD and everything, plus it's ever-changing (while not changing at all somehow), so here's links to the prior two threads:
Initial Thread with Initial DD
Second Thread with some other nonsense
Tried to bump it because we got some news today but it didn't work so here's the update:
Company just released a PR saying that the trial would be discussed by Linda Liau, the principal investigator, at an upcoming conference on May 10.
Absolutely no idea if this is trial results. I actually suspect it may not be. But it also may be. No idea what the heck update she would be giving if not the results of the trial.
Either way, the company has been mum on the trial for over a year and a half. This is the first PR they’ve released addressing the trial so directly since data lock in October of 2020. The conference sent out a blurb saying that Dr Liau would be discussing “exciting updates” regarding the trial. I can’t fathom that exciting updates are a bad thing.
Anybody still in this with me? I know it’s been a while and massive patience has been needed ha. I accumulated a good bit more during the down period. Might be a good time to buy as a swing play running up to May 10. It is already in the middle of a major run likely caused by anticipation of their participation in the ASCO conference in June. Has gone from $0.70 to $1.40 in a couple weeks. Last year for this same conference, the price ran up to $2.20 so I think it could definitely get back there if you're looking for a swing play and not interested in a binary.
I said it in the previous threads but will reiterate, this is a typical biotech binary event and has every potential to go to zero. Upside is likely $10+ conservatively. Biggest risk play in my portfolio.
Initial Thread with Initial DD
Second Thread with some other nonsense
Tried to bump it because we got some news today but it didn't work so here's the update:
Company just released a PR saying that the trial would be discussed by Linda Liau, the principal investigator, at an upcoming conference on May 10.
Absolutely no idea if this is trial results. I actually suspect it may not be. But it also may be. No idea what the heck update she would be giving if not the results of the trial.
Either way, the company has been mum on the trial for over a year and a half. This is the first PR they’ve released addressing the trial so directly since data lock in October of 2020. The conference sent out a blurb saying that Dr Liau would be discussing “exciting updates” regarding the trial. I can’t fathom that exciting updates are a bad thing.
Anybody still in this with me? I know it’s been a while and massive patience has been needed ha. I accumulated a good bit more during the down period. Might be a good time to buy as a swing play running up to May 10. It is already in the middle of a major run likely caused by anticipation of their participation in the ASCO conference in June. Has gone from $0.70 to $1.40 in a couple weeks. Last year for this same conference, the price ran up to $2.20 so I think it could definitely get back there if you're looking for a swing play and not interested in a binary.
I said it in the previous threads but will reiterate, this is a typical biotech binary event and has every potential to go to zero. Upside is likely $10+ conservatively. Biggest risk play in my portfolio.
9
Posted on 5/4/22 at 12:34 pm to Fe_Mike
Still in.
Posted on 5/4/22 at 1:01 pm to Fe_Mike
quote:
Anybody still in this with me?
Yep
quote:
this is a typical biotech binary event and has every potential to go to zero.
Yep
Posted on 5/4/22 at 1:26 pm to Fe_Mike
Still in.
Biotech stocks continue to burn me but I'm ever the optimist.
Biotech stocks continue to burn me but I'm ever the optimist.
Posted on 5/4/22 at 1:36 pm to Lightning
Haha - I’ve had pretty good fortune with bio techs. Obviously been burned a few times but usually I’m able to cut my losses around 20-30% vs my wins have been 5-10 baggers.
This one has been an enigma for me tho. By far the longest I’ve held a pre-rev biotech. Glad others are with me - will be comforting to have companions when the ship sinks ha
This one has been an enigma for me tho. By far the longest I’ve held a pre-rev biotech. Glad others are with me - will be comforting to have companions when the ship sinks ha
Posted on 5/4/22 at 2:01 pm to Fe_Mike
Sold today at $1.50
Bought BTAI @ $13.58
Just taking another wild biotech swing
Bought BTAI @ $13.58
Just taking another wild biotech swing
Posted on 5/6/22 at 10:03 pm to Fe_Mike
Update:
One of the doctors at UCLA had a GBM discussion today. He was asked a question regarding the Phase III (DCVax-L) trial results and he confirmed that the data are being presented by Dr Liau on Tuesday 5/10.
This was a slip up, he was not supposed to confirm that. So we are looking at a massive binary event on 5/10. Very likely the stock runs to mid $2’s Monday.
Then it’s either lambo land or back to work.
One of the doctors at UCLA had a GBM discussion today. He was asked a question regarding the Phase III (DCVax-L) trial results and he confirmed that the data are being presented by Dr Liau on Tuesday 5/10.
This was a slip up, he was not supposed to confirm that. So we are looking at a massive binary event on 5/10. Very likely the stock runs to mid $2’s Monday.
Then it’s either lambo land or back to work.
Posted on 5/6/22 at 11:17 pm to Fe_Mike
I personally wouldnt touch it, although it may turn out to be a solid investment. as far as drugs for rare diseases, I would look for a more survivable and slower progressing condition to invest in. those would be easier to diagnose with better chances of catching early where early therapy could have a stronger impact and could be given over longer periods.
in general...GBM is rather complex, rare, and almost certainly fatal in a relatively rapid time as far as tumors go. their study sizes are small due to the nature of GBM. that means small numbers of outlier type outcomes either good or bad could significantly sway data. which means it could get tanked during trials, or could be approved to only be pulled later.
their trials include 'other glioma's' which are generally much better prognosis to begin with, which may skew the data depending on how its organized/reported.
but some of their data is rather promising and could be a great breakthrough. GBM is just a force of nature that will require no less than truly incredible innovation. but the nature of its severity might give some leeway for this drugs approval
in general...GBM is rather complex, rare, and almost certainly fatal in a relatively rapid time as far as tumors go. their study sizes are small due to the nature of GBM. that means small numbers of outlier type outcomes either good or bad could significantly sway data. which means it could get tanked during trials, or could be approved to only be pulled later.
their trials include 'other glioma's' which are generally much better prognosis to begin with, which may skew the data depending on how its organized/reported.
but some of their data is rather promising and could be a great breakthrough. GBM is just a force of nature that will require no less than truly incredible innovation. but the nature of its severity might give some leeway for this drugs approval
Posted on 5/7/22 at 8:01 am to AMS
What attracted my attention originally was the study taking longer than expected. GBM is normally a death sentence in a short time frame.
The problem with so much of cancer pharma is the drugs have an effect but are massively expensive and it's a small effect. Meaning you end up dead and your family impoverished six months after you would have been dead but your family less financially destroyed.
Binary event. But there's some room for optimism in spite of what a devastating disease we're taking about.
The problem with so much of cancer pharma is the drugs have an effect but are massively expensive and it's a small effect. Meaning you end up dead and your family impoverished six months after you would have been dead but your family less financially destroyed.
Binary event. But there's some room for optimism in spite of what a devastating disease we're taking about.
Posted on 5/7/22 at 9:54 am to Fe_Mike
Posted on 5/7/22 at 12:42 pm to molsusports
quote:
What attracted my attention originally was the study taking longer than expected. GBM is normally a death sentence in a short time frame.
thats why I would expect the study to take longer. theres a short window for participant inclusion and study.
the 5 year survival is like 5% and around 25% of GBM survive past 2 years. phase 2 trials generally take 2 years...thats alone makes it hard to have a rigorous and grossly representative clinical trial.
it seems like the study would require immediate detection and treatment. which is not likely representative of GBM as a whole. I suspect those factors will mean the study probably has bias towards the 'less severe' GBM or patients 'more fit' for survival. this may have data implications in later trial phases which require larger populations studied or in post approval for real world monitoring.
quote:
The problem with so much of cancer pharma is the drugs have an effect but are massively expensive and it's a small effect. Meaning you end up dead and your family impoverished six months after you would have been dead but your family less financially destroyed.
I agree, but I believe the price for DCVAX-L is slightly more than chemo/radiation/imaging. So your point here still applies for dcvax-L unless it has a significant benefit (year(s) not months) over those options.
quote:
Binary event. But there's some room for optimism in spite of what a devastating disease we're taking about.
I agree this could be a truly awesome innovation and I remain optimistic for its results. it could be an incredible breakthrough with implications for combating other tumors as well. but its just not what I would target for a pharma investment play due to the nature of the pathology for GBM and what is involved in clinical trials. I would consider this more of an altruistic investment than a for-profit investment.
Posted on 5/7/22 at 1:58 pm to AMS
quote:
thats why I would expect the study to take longer. theres a short window for participant inclusion and study.
the 5 year survival is like 5% and around 25% of GBM survive past 2 years. phase 2 trials generally take 2 years...thats alone makes it hard to have a rigorous and grossly representative clinical trial
I may be overlooking an important point but it seems to me the high mortality rate in a short period of time is actually a plus when comparing treatment versus placebo variables.
When a fairly large percentage of people are doomed to death within the timeframe of the study? The most important outcome of all can be examined.
Study design is everything obviously.
Posted on 5/7/22 at 4:09 pm to molsusports
quote:
I may be overlooking an important point but it seems to me the high mortality rate in a short period of time is actually a plus when comparing treatment versus placebo variables.
When a fairly large percentage of people are doomed to death within the timeframe of the study? The most important outcome of all can be examined.
Study design is everything obviously.
i would agree generally, but this is a rather rare disease. that means the sample sizes give weak statistical data, their phase1/2 had 39 participants. thats a rough sell for clinical significance even with impeccable study design. pretty much the only thing you could reliably tell from the phase1/2 is that the therapy itself doesn't kill people at an astonishing rate.
how much of the benefit in the trial is just the fact that people in the study were identified early and started treatment rapidly vs the effect of the therapy itself? this point is important because there is no placebo, that would be unethical. its this therapy+ standard of care compared to standard of care.
some of their inclusion criteria basically rule out cases that aren't best case scenario. it requires that radiation halted disease progression.
quote:
Patients must have a life expectancy of >8 weeks.
Patients must have a KPS rating of =70 at the baseline visit (Visit 3).
Patients must not have progressive disease at completion of radiation therapy.
Primary therapy must consist of surgical resection with the intent for a gross or near total resection of the contrast-enhancing tumor mass, followed by conventional external beam radiation therapy and concurrent Temodar chemotherapy.
their data is inherently biased by nature of their inclusion criteria. its selecting for the most likely to survive type candidates. those criteria are kind of necessary and it doesnt mean the study is bad, it just needs to be bolded context when interpreting the study results.
say the study by random chance their study sample included twice the normal amount of 5+ year survivors, this wouldnt be super crazy considering they basically select for people most fit to survive in the first place. that would make it look like a stellar success in p1/2, but may not shake out the same when they 10x the sample size for phase3.
This post was edited on 5/8/22 at 3:20 pm
Posted on 5/7/22 at 7:05 pm to AMS
quote:
this is a rather rare disease. that means the sample sizes give weak statistical data, their phase1/2 had 39 participants. thats a rough sell for clinical significance even with impeccable study design. pretty much the only thing you could reliably tell from the phase1/2 is that the therapy itself doesn't kill people
Agreed. You seem aware that phase two and phase three data have a different purpose. Phase two data are not designed to show efficacy (just relative safety or lack of harm) whereas phase three data are designed to show clinical efficacy.
They completed the phase two data with only thirty some patients years ago. The present phase three study completed enrollment in 2015. It had 348 participants. Additional specifics quoted below:
quote:
currently conducting a 348-patient double blind, randomized, placebo controlled Phase III clinical trial with DCVax-L for newly diagnosed GBM. The primary endpoint of the trial is “Progression Free Survival,” meaning the length of time that a patient continues without disease progression (i.e., recurrence of the tumor). Secondary endpoints include overall survival and other measures.
LINK
Posted on 5/7/22 at 8:46 pm to AMS
Have you taken a look at the blended blinded trial update?
It’s showing the same levels of efficacy. 23 months mOS (compared to 15 months SOC).
The recent reclassification of GBM also greatly helps the study design.
It’s showing the same levels of efficacy. 23 months mOS (compared to 15 months SOC).
The recent reclassification of GBM also greatly helps the study design.
Posted on 5/8/22 at 2:45 am to molsusports
quote:
Agreed. You seem aware that phase two and phase three data have a different purpose. Phase two data are not designed to show efficacy (just relative safety or lack of harm) whereas phase three data are designed to show clinical efficacy.
They completed the phase two data with only thirty some patients years ago. The present phase three study completed enrollment in 2015. It had 348 participants. Additional specifics quoted below:
yea im well versed in clinical trials and have browsed their website and specifics. A phase 3 with 350 participants is relatively weak statistically speaking. its only slightly more than the minimum required, most p3 are closer to 3k than 300.
their phase 3 primary endpoint is to measure time without disease progression. halted progression is a criteria for inclusion in the study. For that reason alone the study is not representative of GBM pathology as a whole it is only GBM in remission. By design the study selects for more survivable cases, which are a small portion of an already rare disease.... that inherently means there is selection bias in their the data vs standard of care in general. although that is probably a necessity for the study due to the nature of GBM pathology, but that inclusion criteria alone (as well as the others) may nullify its use case for a majority of GBM cases.
im not trying to rain on any parades, just providing context for data interpretation. i hope its a groundbreaking success. just an opinion that i wouldnt touch this for money making investment, its more like an altruistic type investment imo.
Posted on 5/8/22 at 3:06 am to Fe_Mike
quote:
Have you taken a look at the blended blinded trial update?
It’s showing the same levels of efficacy. 23 months mOS (compared to 15 months SOC).
The recent reclassification of GBM also greatly helps the study design.
im not sure the blended p1/2 trials are significant (other than its not a blatantly unsafe therapy) considering the trial size is 39... alone either the inclusion criteria or random chance could easily account for the difference.
im unsure how reclassifying GBM helps like you think it might. the reclassification mostly just excludes more survivable astrocytoma mutants from being characterized as GBM. the reclassification was done in 2021, the p1/2 data from this study was gathered prior to reclassification. im not sure how reclassification one year ago could greatly help the study design of a study designed 6+ years ago.
This post was edited on 5/8/22 at 3:19 am
Posted on 5/8/22 at 6:21 am to AMS
Because the blended blinded trial data is not from the P1/2 it is from the PIII trial.
Take a look at this publication it touches on many of the things you have concerns about:
Phase III Blended Blinded Update
Also, are you looking at clinical trials.gov for your info on this trial? Do know the endpoints were changed, and the control arm was moved to an external control arm to eliminate the issues of crossovers and pseudo progression?
Take a look at this publication it touches on many of the things you have concerns about:
Phase III Blended Blinded Update
quote:
For the intent-to-treat (ITT) population (n?=?331), median OS (mOS) was 23.1 months from surgery. Because of the cross-over trial design, nearly 90% of the ITT population received DCVax-L. For patients with methylated MGMT (n?=?131), mOS was 34.7 months from surgery, with a 3-year survival of 46.4%.
Also, are you looking at clinical trials.gov for your info on this trial? Do know the endpoints were changed, and the control arm was moved to an external control arm to eliminate the issues of crossovers and pseudo progression?
Posted on 5/8/22 at 9:53 am to Fe_Mike
quote:
Because the blended blinded trial data is not from the P1/2 it is from the PIII trial
This strangely seems to be a persistent belief. I don't know where he came by the belief
He has a point that the very worst cases of disease are not included in the study but that's hardly a unique feature of their DCVAX-L trial and is transparent.
Posted on 5/8/22 at 10:39 am to Fe_Mike
quote:
Take a look at this publication it touches on many of the things you have concerns about:
Also, are you looking at clinical trials.gov for your info on this trial? Do know the endpoints were changed, and the control arm was moved to an external control arm to eliminate the issues of crossovers and pseudo progression?
I was looking at their website. the endpoints were not changed as far as I can tell between their website and your link. yea i would expect the control arm crossover changes from this type of study.
after reading your link my concerns remain unchanged.
quote:
Unknown factors: sub-group with extended survival
Approximately 30% of the ITT population (n?=?100) showed particularly extended survival,
this paragraph may suggest what I was saying about the studies inclusion criteria giving selection bias. there is a random portion of GBM (or any disease) cases that are just less rapidly fatal and more survivable for a variety of reasons. I suspect that portion is overrepresented in the study due to the inclusion criteria.
also in clinical trials usually at least portions of the treatments, diagnostics etc are free of cost to the patient, those not participating in the study may forgo an equivalent workup and therapy for a variety of reasons. this impacts
im not saying their study is bad or doomed or anything. it looks promising. but there is no clean and neat way to conduct a trial for something like GBM. my concerns would apply to any type of similar study. the inclusion criteria alone, while necessary, insert a selection bias in the data. the sample sizes give relatively weak statistical significance, confidence intervals are kinda wide sometimes.
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