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I'm thinking broad mean....BPs, and "retail" outlets (Walgreens, Publix pharmacy's, etc)...Once DCVax - Direct gets approved I could easily see the "retails" get actively involved...Just a thought.
Fidelity allows sells orders at 8x or 9x current price
Upon approval, I expect wild fluctuations in share price as the MM's will still manipulate to cover as many shares as possible. It maybe fun riding those waves!!
And then boom with franchise deal(s)!!!
I think it's clear that no RFI was requested,
Sorry, getting arts-n-fartsy after a few wines! Got an early start here on the East Coast
"Significant amounts of Company bandwidth and resources were spent on litigations during the first quarter of 2024 (and to date in the second quarter of 2024). The cases are described in Part II - Item 1, Legal Proceedings, below"
As previously reported, three stockholders filed in the Delaware Court of Chancery three similar derivative lawsuits against the Company and certain of its directors and officers,
My question is: will Memorial Day weekend, which starts on May 24th, a Friday, make MHRA decide to move the approval forward or backward??
“The Company did not make any amendment or addition to its MAA after the original December 20, 2023 submission.”
It could mean the company did receive a RFI and they just had to point the MHRA where in the 1.7m pages their question(s) could be answered.
In any event, I believe we are in the final 70 day window from March 7 and we could land on decision by next on Friday!
Next week would be great, however, I'm setting my exceptions for late June just to be safe!!
Lets' roll NWBO!!!
Annual Shareholder Meeting. The Company plans to conduct its Annual Shareholder Meeting before the end of June 2024.
Here is a job for the nemesis!!! LOL!!!
and has also arranged for further mock inspections by specialists who were formerly inspectors for regulatory agencies.
MAA Application. As previously reported, the Company filed a Marketing Authorization Application (MAA) to the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) on December 20, 2023, seeking regulatory approval for commercialization of DCVax - L for newly diagnosed and recurrent Glioblastoma (GBM). On January 24, 2024 the Company received notification from the MHRA that the MAA had passed validation. On March 7, 2024, the Company received notification from the MHRA that the validation was confirmed. The Company did not make any amendment or addition to its MAA after the original December 20, 2023 submission.
It's amazing that a 100k bid at 50 cents, 30 seconds before the close and we end up down to .488 on a 114 share trade. This is so laughable, that all it takes is $55 to drive the price down 2.4%.
It is truly amazing how LOW the FUD's will stoop in order to sabotage this company.
I am a God fearing man however, I believe karma will become these MFers and they will be begging for this treatment for one of their loved ones!
Settlement is coming soon, imo.
and this!
our results support the conclusion that DC vaccination with poly-ICLC induces Type I and Type II IFN responses more effectively than with adjuvant resiquimod or a dendritic cell vaccine alone.
Since submission we have been dropping an average of 0.019 cents per week...
Hopefully soon, the trend will reverse...
139 day down and perhaps 71 to go. At least we are 2/3's the way there.
We should be at the tail end of the 60 day RFI if all 60 days of the RFI were used.
Another day closer!
Keep in mind, today is only day 138 from submittal so we have a ways to go while we wait in limbo....
Unfortunately, until then, expect it to continue until we get news.
The lawsuit will go to discovery and we’ll find out who they are.
Thank you for the reply!!
I'll ask again...
If they are moving forward building more labs and units does that indicate the MHRA approved the new units?
Why move forward without approval?
including beginning initial construction works for the first grade C lab
Any interpretation on the MTD filing yet?
Volume hasn't been this low since the end of June 2023.
Eye of the storm!!
I don't think the shorts are too worried...I had 55k of my shares borrowed this week. Time to exit the loan program. its only $10/day in interest.
it was deleted before I could read it...what was the gist?
I wonder if the Judge can dismiss MTD after he reads the defendants arguments and without waiting for the plaintiffs rebuttal.
Wouldn't that be nice!
Yes.
I was thinking it would be Merck for the longest time, however, I now believe it will be AstraZeneca. I believe Merck wants the whole enchilada and not open to a franchise arrangement, thus I believe AZ would be a better fit. Also, Walgreens hired an AZ exec some years back....
In 2017, Walgreens appointed a former AstraZeneca executive to lead their market access efforts. This could suggest a pre-existing relationship or potential for future collaboration.
Pure speculation on my part....Lot's of free time to speculate as we await approval decision!!
So who do you think?
Is it this company?
We are a global, science-led, patient-focused pharmaceutical company. We are dedicated to transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet.
Creating the next generation of therapeutics using an array of drug modalities, for example, advanced biologics, nucleotide-based and cell therapies.
We are leading a revolution in oncology to redefine cancer care. Our ambition is to follow the science to discover, develop and deliver life-changing treatments that transform outcomes and increase the potential for cure.
LC, what do you think, a 3rd party wanting to control NWBO? ??
Thank you!
Probably why the June 21st options are plentiful!
Do you know when is the FDA decision?
I recall it was early June. The 12th? But not certain. Thanks
The 110 was from submission...The only date we know 100% certain.
To think the MHRA won't have at least one question is unrealistic, IMO
Most likely, scores of questions and thus the fully engaged on approval....They have 60 days to answer.
So, BMY also likes to expand cell therapy via franchise. Interesting.
About 3 weeks ago!
I suppose, around the window for RFI (around day 110).
Excellent thank you!!
When asked about status change...reply was they didn't know what I was talking about....Hmm
Maybe, just maybe, there is more to it. Speculation on my part, of coarse.
It's hard for me to believe there won't be a RFI....
"We are focused getting the therapy approved"
"We have a great deal on our plate"
"We are fully engaged with the MHRA"
"Go back and review what was said about the application"
IMO, the above can be taken that a RFI is happening....So I believe decision time will be July...Again, if it is sooner, I will be thrilled!!!!
You talked to the company
“ Theoretically, if no RFI is required, the application could be decided on within 150 days. “
If you talk with anyone from the company, you will learn they all are working their tails off to get it approved.
This means they got a RFI. Besides, it is unreasonable to think that with a 1.7m page submittal, the MHRA wouldn’t have any questions.
It is best to assume near worse case and that is a 210 day process. Anything less than 210 would be fantastic.
Back to back up days....Yahoo...Haven't seen that in a month!