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Hopefully, NWBO makes a move to somehow acquire Oncovir in the future.
With how their product greatly enhances DCVax-L, an acquisition of that nature would be tremendous, especially so when the publication for the combo trail comes out.
If I said that I do not like surprises, or if it's not possible, I would be a liar.
That being said, my previous point stands: If they did, don't you think NWBO would WANT to inform us of an FDA submission?
The following is an excerpt from the attachment you provided:
Dstock,
You are going to make people believe the possibility of an FDA submission, even when NWBO has not stated so.
If they did, don't you think NWBO would WANT to inform us of an FDA submission?
False expectations and speculation will hurt us more in the long run. Stick with the PR.
No.
They stated that they plan on submitting to multiple regulators. So far they have submitted to one and PR’d one.
If they submit to the FDA, that would be a material event and they would PR that submission as well.
No. NWBO would have PR'D this.
Please, PLEASE stick to the last PR everyone. You are creating false expectations.
Quite amazing, isn't it?
More profitable to treat the symptom, not the disease.
Weird, isn't it?
😏
I believe what you are saying is the likely case.
$NWBO @EndBrainCancer
— SouthernTrading (@SouthernDrive21) April 5, 2024
Help DCVax-L Gain FDA Approval.
IMO only, I believe NWBIO is nearing FDA application submission. Thank you https://t.co/RUsj8KSN4K for your initiative. https://t.co/AaPGw8xnishttps://t.co/Hh5unWdnz6
Raise your Voice for DCVax-L… pic.twitter.com/7XUaWsn1PB
I agree. I remember reading the 10k from last year (summer/fall time?) that they were in discussions with a CMDO in the states.
We'll probably get an update shortly after the MHRA decision, among other catalysts.
I'll take a stab at it:
1.) FDA Submission
-Unlikely: I would assume NWBO would wait until Flaskworks is approved, and another CDMO in the US is contracted out for capacity concerns. Also, no word from NWBO other than the MHRA submission.
2.) Compassionate Use
-Possible: Internal "buzz" on DCVax-L within the medical field and the FDA's interest is peaked.
3.) Charity/Medical Activism
-Possible: Non-Profits and charities pushing the envelope to get the regulators attention.
4.) None of the above
-Probable: We unfortunately won't know until we know.
This also caught my attention.
I wonder in what capacity this data is being presented in.
This has nothing to do with QMC.
Smitty, let me explain the problem to you:
You, on numerous occasions, state and/or exhibit yourself within your posts, with a level of certainty, that the information you have/know/believe is 100% factual and correct. You place yourself on top of your soap box and declare to all on this forum the absolute certainties of your word. Yet, when some (whether gullible or not) confront you, you hide behind the safety of "Plausible Deniability", and conjure up statements such as this:
Smitty...........oh SMIIIIIIIIIIIIIITTTYYYYY.....
Maybe a day to him is not 24hrs, but more like 48....or 72hrs.
We'll never know unfortunately 😮💨
Technically, he said shorts have 8 days. Today is the 8th day.
So perhaps tomorrow 🤣
I believe that is the sensible approach
I've been saying this.
We will need a footprint in the US for the FDA to be comfortable, imo. We know this is already in the works from the previous 10k's.
This is what I believe is needed before FDA submission:
1.) MHRA Approval
2.) US Based Contract Manufacturing
3.) Flaskworks Approval (added bonus)
Also, the logistics and planning for our eventual ramp-up of DCVax to the public will take time, money and will come with several lessons learned; it won't be instant and it won't be easy. The UK is the best place to start and learn.
Once we have that set in stone, an eventual rollout in the US will be much easier.
I wouldn't hold your breath. If nothing happens he'll either stay quiet about it or make a reason as to why nothing happened.
Amazing how in the last 45min the stock tanks right back to where it started.
Manipulation at its finest.
Yea, pull back was too severe.
PPS never surprises me.
Just can't help yourself, can you?
DCVax-L is not eligible. Read StonkMasters reply:
1. DCVAX-L is not an Established Medicine (which most of these procedural changes are for - it's in the title).
— StonkMaster (@StonkMasterJ) March 28, 2024
2. AFAIK, DCVAX-L would not be eligible for an assessment under either the MRDCRP or ECDRP pathways.
For NAS MAAs, I don't think much has changed. 150 day assessment.
Anyone remember the wild infant from the cartoon "The Wild Thornberries"?
This is sir pumpernickel.
No one takes you seriously.
If word comes out that the Royal Family is taking our therapy AND his tumor receded...
Oh boy would that be explosive 💥
Probable, for sure.
We've had these PPS spikes before. Let's see if it continues and holds.
Not required.
But you know that.
Amazing.
CDEL and NITE doing their thing again.
30k block from CDEL
Hoping it's not a "spur of the moment" like it has been in the past.
Wondering if some are hoping/expecting an approval announcement next week. Far to early IMO, but you never know these days.
Christ is King
Question Doc,
In a hypothetical situation, let's say that the inspections from the MHRA are delayed and it'll take the first half of 2024 to complete (basing on the statement from the 10k). Is there a possibility that NWBO was skipped in the March CHM meeting, and can be in the next CHM meeting instead?
Sorry, perhaps I should ask again:
I know, I was being a bit sarcastic.
But their vernacular and speaking methods are very similar, along with their "predictions" and "know-how".
His new name is Smitty /s