lindas have a posse
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Are you Dave Innes?
If not STFU and sit back down.
Yes as Bard says:
Management, in my opinion based on the science and their statements, have the cure for all solid tumors. They met their MAA submission goal for 2023 yet can't get any positive feedback by some on this forum. Ultimately it doesn't matter what people say here as the company and shareholders are focused on one goal: global approval for DCVax-L.
Yes we do
Dirtbag
I agree it won't matter who's right or wrong on MHRA decision timetable as we're all heading for the same outcome, in my opinion: massive wealth.
If no RFI letter is issued by MHRA there is no Phase 2 assessment hence why majority of decisions are made in Phase 1. Read more below:
https://uk.practicallaw.thomsonreuters.com/w-029-1301?transitionType=Default&contextData=(sc.Default)&firstPage=true#kh_relatedContentOffset
I do not expect MHRA will need Phase 2 assessment for DCVax which they already know works given Specials, JAMA, PIM designation, orphan designation, and patient advocacy.
I could be wrong but I do not really care as it will be approved in 2024. I stand by my timetable of March 2024 as it has a high probability of being reached.
I don't care if people disagree with me as MHRA will be making the decision while their own data suggests it could come in less than 150 days.
flipper44 and others have posted this multiple times:
Less than 150 isn't early approval nor would greater than 150 be late. MHRA outlines a process for evaluating the application which they document clearly with performance metrics that give us some basis to know how long it takes them to make decisions. Multiple posters here have linked to those reports which are on MHRA's website.
I expect approval will not take 150 days as MHRA performance criteria suggests this outcome highly probable given management, in my deduction, took extra time to ensure an error free comprehensive submission.
Calendar days yes not working days. Approval by March or February at earliest.
One day closer to approval. Never felt better about Northwest Biotherapeutics.
In my opinion, based on MHRA criteria, NWBO will announce MHRA acceptance of application by January 12th. So we could hear of a partnership in a matter of weeks.
I agree that DCVax-L will likely be our blockbuster drug with Direct being more niche.
With improvements in early detection methods I believe efficacy of L can be improved by administering it to patient before cancer spreads throughout the body.
Love you Gary! Hope you are doing well!
Ex said it would be in readers digest.
What a fucking LOSER!
Trillion-dollar technology!
Looking forward to that outcome, ATL. Happy Holidays to you and yours!
Dave told me to chill. He was correct per usual.
They will stop posting when a judge takes away their internet access.
We are not in the same position, with submission imminent, as in 2020, 2021, or 2022. Suggesting we are seems grossly irrational.
I agree Hoffmann.
Congratulations longs. This week the manipulators lost.
$100B company.
I don't care what we're trading at now.
Either you understand the fundamentals or not.
DCVax in NATURE and this isn't even our PII Combination Trial!
I will also stop posting if we do not have submission by January 1st 2024.
Sequencers are standard lab equipment.
I agree newman2021!
Management in my opinion are working hard to deliver results for patients and shareholders.
I remain focused on the end goal: MHRA approval which Dr Ashkan said would likely happen in a matter of months.
In the very near term MAA submission could occur anytime as well as our Phase II DCVax PolyICLC Nature paper.
January we may get more combination trial results as well.
In summary there's never been a better time to own Northwest Biotherapeutics stock.
I will that to my relatives in the next few weeks who like me own many common shares.
Happy holidays to all shareholders in this revolutionary company!
Dave told me on 11/22 that the publisher had majority of application and began their process before MAA submission. This aligns with their last news release.
He also told me to "chill."
I encourage longs to heed this advice. Many are seeking our capitulation when we are on the cusp of submission. Linda will get it right. Management have had nothing but success.
Nature could drop anytime as well.
Let's enjoy the holiday season.
I am no longer posting on this forum until post MHRA approval. There's nothing more to discuss in my opinion as the outcome's inevitable.
Longs should be engaging in estate planning, like company management have done, not arguing with people who think the earth is flat.
Buy now or cry later!
I agree JD.
The off clock period isn't required while approval could be done in 80 days or less if MHRA doesnt have additional questions. I believe a lot of this information was already completed with regulators knowing much given the MIA as well as our existing orphan status.
How many shares has HyGro's fund bought since Data Lock? I think a lot. That explains his attempts to shake us out before MHRA approval.
Merck already doing trials with DCVax.
Not happening.
(thank the lord)!
I would pin JAMA
NWBO centi-millionaires lend me your ears!
I did Happy. I think we would be like peas and carrots if I get chosen!