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.
Yes I expected the ramp up to capacity 5-600/year immediately after approval.
However it will take some time ramp sales though.
One thing is capacity another is sales, ask the guys at Amarin.
Not buying anymore before we see sale numbers in line with max capacity and beyond.
Do the we know what costs of product sold will be ?
Currently valued at 9 x max sales with the new capacity.
Assuming $150K x 500 patients = $75M
Seems optimistic at this time, and will prolly come down a lot unless sales pick up really quick after approval.
When will they be able to ramp up productions beyond 500 patients ?
I am not alleging anything, I just don't think it is good business ethics having the CEO as the main owner of our only production facility, period. Arms length and transparency ris required.
The facilities are(were) not that expensive so we could easily have build it ourself. And going to others CDMOs with little knowledge of DC production makes no sense and prolly as you say would have been much more expansive. So having to chose between two evils I chose the current solution.
Would like to trust in what you say.
Why do you think this is a modular agreement. I have not been anle to find and info of the content of the agreement.
It is unproffessionel to assume any partner will act in your best. you have contracts for that. I think the shareholders need transparency on the financial terms, simply to acquit LP and avoid failty play.
She is both CEO and CFO and owns our only source of production ? Hmm she use to work for Enron right ?? F@“k LOL
She might have good intension but what happens when Advent raises prices, who will deals with that our CEO or CFO.
It seem to me that all the production license are awarded Advent and not NWBO. Who eould our SP increase due to that?
Great!
Would be nice but that was back in March 17th
Doesn't it seem very risky and short sighted to build out DCvax productions at Advent. Why doesn't NWBO own this ??
Who owns Tucan Holdings Llc which own 75% or more of Advent Bio ?
Almost at the point of deleting my Twitter account. Negative vs positive sentiment when searching Icosapent Ethyl is 20 to 1.
Bhatt mentioned this recent report was just one of many more data and it didn't mean anything ??? So when will he /they release the rest of the data.
Seek of this BS, but trapped with my investment in AMRN.
Hard enough to launch a product on positive science, but this will be crazy tough.
I guess one of Nissens friends ?
This Webinar is brought to you by the ASCVD & Lipidology Knowledge hub supported by Novartis.
Join Prof. Stephen Nicholls for this interactive webinar, designed for health care professionals who are interested in learning about the latest research, treatment, and clinical management of patients with cardiovascular disease.
https://events.bizzabo.com/384552/home?elq_mid=63075&elq_cid=33226115&utm_campaign=39197&utm_source=eloquaEmail&utm_medium=email&utm_content=EM3__RM-NGP_BBR__Novartis%20Lipidology%20Website_R7D689W
No one knows how PFS can work in the keytruda combo trial when it didn’t work in our own trial ?
Are they combing MRI with biopsy, bio marker or ?
Guess just MRI wont wotk if it didn’t work before?
PFS OR OS
Can anyone explain how PFS as primary end point is gonna work in the Keytruda combo trisl
Saw that looking forward to see his answer
Thank you for your answer. Makes a lot of sense.
I agree Evaporate data was of great support and crossing finger for Mitigate.
V kind of got approved on the wrong data, although Evaporate not done at that time, so to say.
Has anyone been able to debunk the increasing lipids in the placebo arm, other than increases were too small to have an effect more than 3%, I think it was.
Do you know how those lipids develop during 12-24 mth statin trials ?
The isn't bashing, but DD and trying to question new data, looking for info among all the educated and clever people here on the Amarin board.
Brilliant that would have solve all the MO issues, seriously !
Did the copenhagen data mention anything about these biomarkers increasing in Popl. ?
Seriously the trial was powered for stat significance, so anything happening in the placebo group must be attributed to the only difference between groups V or MO.
Or the placebo group started eating pure fat after entering the trial ?
Are those increases normal for these kind of Pts ?
Is there a benchmark not being V arm in this trial ?
Do you have any other trial to compared baseline biomarker. It seem placebo group markers rose rather quick.
Maybe I dont get it, but the placebo group biomarkers increased a lot indicating that he intergroup comparison favored V based on the placebo group doing bad.
Meaning V didn't do anything god, it was the placebo group that did bad.
Change my mind please, as I am long time holder and would want it not to be true.
Just reading the test data and conclusion. New data =new conclusion, i guess
Really bad timing of this new analysis considering reimburse discussion in Europe.
Does it, maybe, but there is a hair a new hair in the soup.
This new analysis shows that MO had a bad effect on placebo Pts biomarkers and could be the reason for the positive effect of V compared to placebo.
How many more blows can we take ?
Beginning of the end for V ?
https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.059410
insert-text-here
Thx, I misunderstood what she said.
Odd thing to communicate, never heard something like this before. Think lots of people would not understand what it ment.
Was Dr. Liau being creative in her communication, trying to boost share price ?
Anyway it's history, what we have now is the TLD.
THX, just wondering with so few AEs.
Thank you very much for your kind help. Will certainly have a look at your links.
I get what you are saying, wouldn't it be great, but I don't think they have any good news hidden anywhere.
KM curves are mathematical projection of survival, and will change as pts die, so will have changed since 2018. Maybe we have a statistician on the forum that can explain how this changes.
I read this as a mistakes e.g. from 2018 "182 patients are?≥?36 months past surgery; 44 of these (24.2%) have lived?≥?36 months and have a KM-derived mOS of 88.2 months. "
both >= 36 mth ?
Naa, I'll be looking purely at the end score which is the TL
Interesting to see if those on Bev did better. Love to see patient stats.
The missing patient data and internal control, I think is the main reason why we haven't seen and per review yet.
NWBO need to did deep and do the stats properly.
I think it a fair question as part of my DD.
But maybe you can direct me to a dose escalation study, that holds the answer.
Thanks in advance fore your help.
You might be right, it's above my pay grade
I really don't know why, as I think patient's Vax would be less effective as their tumor would most likely have mutated.
Everyone in the crossover should be nGBM otherwise they completely f...ed up the trial. Trial entry criteria was newly diagnosed.
If they weren't nGBM, the mOS would be out of this world :-o
It's like a football match.
Half time scores doesn't matter.
In the end the trial read out as presented in the top line data.
That said the 2018 data are confusing, I suspect it is not a try mOS but only with a selection of clients, thus giving a über high mOS, which of cause in the end when measuring against total patient population didn't stick.
Confounded, yes.
Would love to see a swimmers plot on this trial.
Seems more than odd to me that there are more pts living at 30 mth or 36 mth back in 2018 then on the TLD. That is not possible. Unless those 2018 number were statistically projected.
Whatever the data said in 2018 we can no longer use.
It is sad that the trial is so sloppy, which is feeding the industry questioning the data.
Looking forward to see the presentation on internal controls that they promised for June.
Do you have a link to where Askhan mentions Top 100 with mOS 7y ?
I am sure if there were more than 27 pts alive at 5 y they would have included that data.
No one hides good data
That would be nice, but feels a bit wishful.
The unaccounted for who are ? The 35 pts not in trial ? (331-232-64=35)
I believe the 35 pts were not included in the trial because due to early progression within 6 week post SOC. But Ashkan did say at the BNOS conference that less than 10% did not cross over ?? who are those pts and why didn't we see the survival data for those patients. Prolly would be 7-8mOS.
Anyway how do you get to 13 additional pts with 5y OS ?
Although no info on when pts relapsed and crossed over, using the historical data, pts will relaps after 7-8 mth post surgery. So adding 7-8 mth to mOS in rGBM 13,2 mth = 20,2 - 21,2 mOS rGBM live 1-2 mth longer than nGBM with "only" mOS 19,3. Could mean that the randomized control grp was less sick than the DCVax grp or there is a benefit to have DCVax after progression. Does SOC knock down immuno system so that DCVax is less effective in pts than in those who have recovered Soc ?
Thanks for clarifying