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hahahah lol I would not go that far but I happen to be called a fossil but that probably has more to do with my know it all savvy kids
One thing we can be sure of is the FDA has seen trial data and if they did not like the data they would have stopped/warned NWBO from proceeding with the compassionate treatment as what they are doing now, full steam ahead.
What signal would the FDA, UK/EMA give if they later this year would dismiss DCVAX L to patients that have been treated.
Unless you need that money soon, there are other options to consider like contacting one of those law firms that have investigated NWBO or filing a regulatory complaint about the failure to release TLD within 12 months of data lock. The law firm could always announce they are investigating the issue and that might shake the information tree.
This argument would be laughed out of court for one reason in particular - COVID
Like I said before
this month 80% or max Feb 95%
80% in Jan
95% in feb
100% in march
But end January or first week Feb
I think they may have had pre-BLA meeting(s) late last year and would be close to submitting their final BLA this quarter closely on the heels on TLD+publication
many have asked you questions that you have left unanswered so Im a bit reluctant to answer your question for that reason. But ok.
There are certain circles that have proven to be very reliable to me even more so than LG. And that is because LG has not been that reliable over the years. So firsthand info does not need to be super reliable perse.
But my sources are the second of your equation and your conclusion that such is thus less trustworthy is not my experience.
I Cant say anything more than I already did other than Im not just saying that. And I fully understand you take it with a grain of salt
I think the delay of results is due to the delay of the publication which is in turn due to covid. I have heard (reliable outside this board) its very very close (publication).
Since the publication is not in the hands of NWBO it would be a complete waste of time if meanwhile, NWBO had not worked on BLA and expedited approval but in what phase that is I have no idea.
I dont understand what you are asking
I don’t think they have filed a BLA either. I do believe they have drafted the BLA and are almost ready to submit
And yes Senti and anyone else who wanted to know, I type out everything I post every single time
thanks dec 2016 how time flies
Challenges of designing & evaluating clinical trials for immunotherapies in the GBM field is nothing more and nothing less than what we have heard Dr. Liau discussing last year and what has been discussed in The Lancet journal article in Oct.
Simply put:
For a trial in a lethal disease such as GBM you just cant from an ethical standpoint maintain a placebo control arm especially when the treatment is working. In other words, you can not let the placebo die so the statistics will benefit better.
And of course that's a challenge for its new
She might care, just depends on what she drinks.
If I understand the sentiment here, Stupp is evil, but Dr. Liau, who is sitting on a miracle cure for GBM since 2015 is a saint. I find that, shall I say, curious
Every dev stage bio I know of has disclosed BLA plans.
the only case on this that had been posted here concluded that the issue would be saying anything at all about it w/o disclosing the negative details. Staying quiet would have b
But there are specific milestones listed in the contract. Other than the first (mainly paperwork) they have disclosed none have been achieved.
yes I agree NWBO should improve its communication.
But Im 100% convinced they will make it up with us very soon!
* What is the contractual deal with Advent for manufacturing in Sawston.
I agree with this one
. Where does the Flaskworks project stand.
we know work in progress
. Have they unblinded the database.
of course they have see my previous post. If they had not then they have misled us
. Have they updated the IND with the FDA
NWBO chose to disclose that when results are submitted as I have sowed they can
. What was the FDA response.
If negative then they should have disclosed no news means good news
. Did they have the pre-BLA meeting with the FDA.
That is not what biotechs disclose ex and you know it
. What was the response.
If negative then they should have disclosed no news means good news
. Have they started on a BLA.
That is not what biotechs disclose ex and you know it
. What happened to the IA that you said would happen in mid 2015 and have never followed up.
Ooh please
I however agree that NWBO should improve its communication.
They can't even give us an update to where they currently at at this very moment
I think this month 80% or max Feb 95%
80% in Jan
95% in feb
100% in march
lol well you already have the sunny beach to enjoy
I understand your frustration but Im really confident it will not be long until we see the publication. I promise
You have to have some faith in management. If you think they are playing games to keep us in the dark then that's not a good investment thesis.
Im confident that all of NWBO management wants this approved as soon asap and if they have concluded it's not feasible they would have disclosed that as SEC requires many months ago. Its good they did not
no legally there is not. I have been posting about this already and have little time to go over it but there is legally really not.
short. First of all, they have repeated in their 10Qs and K that they are seeking publication. If they have been declined over and over, over a set of time which is reasonable to get published then having that statement still valid is misleading.
If Im a listed company in Ice cream and I say I will manufacture banana ice cream then after how much time not doing so and failing to do so, is that repeated promise misleading? 1 year? 5 years? 100 years? 2 attempts, 5 attempts a 100 attempts? It's within reason that a prudent investor may expect the ice cream company to produce banana ice cream within a reasonable time for one can expect the Ice cream company has knowledge of how to produce banana ice.
There is a beginning and an end to a forward-looking statement and NO under safe harbor, the listed company can not keep saying and promising the heck they want. I have posted about this extensively a few weeks back and quoted several sources on this
if the article has been rejected then that fact should be disclosed for NWBO has stated they are seeking publication. In other words this:
These processes included data validation, analyses of the data by independent statisticians, preparations by the statisticians of summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and independent experts, in preparation for publication in a scientific journal and public announcement. This series of processes is under way. It is anticipated that public announcement will follow these processes.
I have to consider this for a while.... but I might ... I might give you $5 if you stop with the
You are saying its complicated and therefore you think discussing is a waste of time? That is your opinion.
“Conceding” they are in violation of law is not a factual thing.
In general, pending publication would not be considered good cause for an extension.
1) Saying that NWBO's failure in general to not update the US clinical trial registry is not the subject is odd. The issue being asserted is if NWBO is required to update it. I know they do not.
2) Is about "primary completion date", not results submission. They are unrelated. The primary completion date was known months prior to Oct 5, 2020. This was a required update in one month having nothing to do with results submission.
3) This one can be argued. But the protocol change was publicly known to patients. Does that count as communicated?
hahaha
Deja vu is the same experience when you get deleted over and over for no reason what so ever lol
Ex knows sure knows how to find TOS button lol
out of posts will be back tomorrow
wrong
(A) In general, changes to clinical trial registration information specified in § 11.28 must be updated not less than once every 12 months
(I) Primary Completion Date must be updated not later than 30 calendar days after the clinical trial reaches its actual primary completion date. At the time, the date is changed to “actual,” and the Enrollment data element specifying the actual number of participants enrolled must be submitted.
(O) If a protocol is amended in such a manner that changes are communicated to human subjects in the clinical trial, updates to any relevant clinical trial registration information data elements must be submitted not later than 30 calendar days after the protocol amendment is approved by a human subjects protection review board.
you and ExW are really discussing a failed trial.
exwannbe I think I said before already here that almost all failed medical trials with any medical meaning will for future references and to inform the scientific community be published at some point. So congratz on finding two. It would not surprise me if more failed trials are published than successful trials.
However, most failed trials are published 2, 3 years after topline data was announced by the sponsor and are published by the lead investigator on a sunny Sunday afternoon.
I said therefore specifically all this trouble NWBO is going through to get a publication is only for a highly successful trial. As would with any other biotech..
ok thanks clear we agree
Im not really familiar with Novocure but how much revenue of its 400 million would remain if all of its GBM related sales would be left out?
Isnt that close to 80%? and what would the market perceive Novocures other upcoming devices if DCVAX L were to be approved?
That may be the case with many biotechs, but I personally do not believe that to be the case here.
Flipper admitted earlier today, they knew things were going to take far longer for years and that shareholders ‘did not have the stomach for it’ and were not forthright about it.
I cant respond to PM but it is horrible I know
Btw he is a she :)
If safety isn't a concern I don't think you'd here back in 30 days from the Agency but if they have other issues w the SAP/endpoints you would find out about it in the meeting/meeting minutes.
sorry I misread I though it said 6 months :)