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See how fast they dropped the price? SH have never, ever been in control of this stock, and the company....clueless.
I was sarcastically poking at posters that have tried to knock Flaskworks by saying that the comparability studies will essentially require another trial.
"They're going to have to do a whole additional comparability trial before they can use Flaskworks for DCVax"
As soon as the GMP-grade units are delivered, Advent BioServices will undertake final qualification and validation of the GMP units and use engineering runs with the system to collect data in order to submit an application to regulators to approve the use of the system for production of DCVax-L for patients.
The Company is optimistic about this approach because the Flaskworks system now closely mirrors the existing manufacturing process, and the DCVax-L products manufactured through the Flaskworks system are substantially comparable to the DCVax-L products made through the existing manual process.
I wonder how real these are, in actuality, and if anyone has tracked the signals with results
That's 700.
7000 share premarket trade up.
"move the price up" signal.
Interdasting.
Aww, sad that I am still here decimating your arguments?
Riddle me this, batman.
If the deferral to start after submission inherently implies that it must still start prior to approval, why does the MHRA state this with regards to deferrals:
6. Annual report on deferrals
Marketing authorisation holders with an agreed UK-PIP who have received a deferral must
submit annual reports to the MHRA. An annual report should be submitted for each PIP even
if there are several PIPs for the same medicine. The first annual report should be submitted
within the period of twelve months beginning with the date on which the licensing authority
granted the deferral.
The annual report should update the MHRA on the progress of paediatric studies in relation
to the agreed PIP decision and deferral. This information should be submitted via the MHRA
Submissions homepage using the annual report page, navigating from the PIP homepage.
After maa submission is not after maa approval.
Keep on wiggling, Flip.
I've had enough fun with you for today.
Feel free to keep posting and convince the sheep that combo trial news is guaranteed soon cause Linda Powerless said so. Hopefully your pump works.
The agreement was not for post approval, it was for post maa submission.
What is the current SOC? Chemo radiation.
How did NWBO conduct the nGBM trial? With initial concurrent Temodar and DCVax-l.
Some years ago, some of you may remember, we had hoped to embark upon combo trials years ago, and we actually have reached conceptual agreement with several other parties, and we announced this to do -- to proceed with combo trials.
Unfortunately, from a resource standpoint just couldn't do it from a resource standpoint, and we had to just stay focused on getting our lead program to the finish line, right? But now that the Phase III trial is done and as soon as we've got the application for approval cemented, we're very eager to proceed with these combos. I will say we -- again [indiscernible] about the past, we will be looking for the terms to be favorable for Northwest than its shareholders.
As I said, not the 'combo' we or anyone means when talking about combos wrt DCVax trials but you know that.
But whatever, play your silly wordsmith games so you are 'technically' right. I don't care.
Answer the other question.
Where in that statement does it say that the trials must be started prior to MAA approval?
The actual approval decision just lists 2 trials, DCVax-L for nGBM and for rGBM patients under 18 and at least 6 pounds. No more detail.
So it says they do not have to be initiated prior to submission. Where does it say prior to approval?
The pips are also combo trials.
“The approval may include a deferral allowing the pediatric clinical trials to actually be carried out after the MAA has been submitted, but the PIP approval itself must have been received before an MAA can be filed and go through compliance check.
Northwest Biotherapeutics worked with expert consultants for months to develop a PIP tailored for application of DCVax-L to pediatric cases of HGG. The Company submitted its proposed PIP to the MHRA in February 2022, and has been going through the regulatory review process since then. On August 17, the Company received final approval of the PIP from the MHRA.
The Company’s approved PIP includes a deferral under which the pediatric trials are anticipated to be undertaken after an MAA application has been submitted.”
At least one combo has to be initiated before approval. See PIP. That, I am stating as a fact.
At least one combo has to be initiated before approval. See PIP. That, I am stating as a fact
Timing is the hardest thing to nail.
On a previous occasion, you were convinced no MIA was coming, and just a few hours later it was announced.
Exactly. Which has been my point all along.
Back in early January I told you that you had no idea what that meant, even though you were stating it as a matter of fact, and that you were just hoping.
Now you are admitting that you were just hoping, but were obviously wrong.
You are still just hoping.
Stop trying to tell people that LP's statement during the 2022 ASM meant that combo deals would be locked up at a certain (ambiguous) time after MAA.
She did not say that. You are hoping that's what she meant, but it is simply you hoping. It didn't mean anything.
She said they would start progressing on combo trials after they had the MAA behind them. Whatever the hell that means.
No riddle.
Flipper at the beginning of January:
Where are they? If Senti is correct that the maa has already been validated (aka “cemented”), where is the outcome of those over year long active negotiations?
Cement was obviously not acceptance
Then again, I ask you, what exactly is it you are saying?
Stop talking in riddles.
Cement was obviously not acceptance. Next stop, 80 days or less.
I literally have no idea what you are saying.
Speak English. What you just posted does not mean anything. If you're going to make a prediction, make it. If you're going to talk in concrete riddles and change your definition of 'cemented' every other week, please stop replying to all of my posts.
You originally said that MAA "cemented" was when they submitted and we should get partnership news very soon.
Now that it's been a month and a half, you're saying what? That "cemented" doesn't actually mean MAA submission, it means....RFI? End of Phase 1?
And I bet when we don't have partnership news then, you'll change your tune to "ah, MAA cemented obviously meant once it was approved".
Say what you think using real words, or stop talking.
3 months from now we STILL may not have diddly squat.
.40's this week. I see nothing to stop it as nwbo hibernates from SH and the world. Mis managment at it's finest.
kabunushi said:
In my book that makes you a bit stupid
Kabunushi said:
You sound like a penny-ante trader pretending to prove you are smart because you 'know what they do'. Sorry, you're a total joke.
Something seems wrong with you. Are you senile?
Haha, your self righteous, holier-than-thou attempt to patronize me is falling on deaf ears buddy.
I’m sure it makes you and your pumping buddies giddy though, so feel free to keep attacking me.
Odd that you singled me out, when posters like Newman, Crash, danish dude, and others spend pretty much all day every day responding to any posts I make with insults and personal attacks while not arguing any relevant points. And you’ve yet to criticize them for being childish, classless jerks. Funny, that.
Are you having anger management problems or are you simply stuck in your teens WRT your social development? Just to offer some free advice - that's a stunningly bad look.
you wouldn’t have understood that before Regeneron’s move
You just want cheap shares Doc. OK, so can see I’m fighting traders salivating at these low prices. Over and out.
, not by pricing a company by its market cap getting crushed prior to and probably after approval.
Please speak in complete sentences, I have no idea what you are saying.
What is "that"?
The quality of your posts is rapidly diminishing.
What FeMike is saying is that the right information and the right amount of time can get to what you are talking about but that we must first bridge that gap.
I mean, just keep showing everybody how little you know about economics.
Have you noticed that nobody is running to your defense and agreeing with you? Everyone here loves to take every opportunity they can to bash and disagree with me. But not a single poster here believes your bullshit nonsense that NWBO is going to get bought out at a 1000%+ premium enough to actually take your side. Because they know you are dead wrong.
You probably also said that right before Regeneron made a 4x plus premium purchase.
You can fucking pound this company,