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Thanks Single Stock. I agree with the numbers in your last two posts except for the 'modest' $250m upfront payment. I believe any combo trial with nwbo will be a backloaded milestone based deal and the upfront payment will be much much lower. Ultimately, this ends in a buyout.
p.s. respect to those that have a much higher valuation in mind. The possibilities with the platform are endless. 🙂
anyone know the 5th civil spoofing case identified by D's in their recently filed objections?
https://www.reddit.com/r/NWBO/comments/1990v3j/what_is_the_5th_civil_case_identified_in/
The list of Defendants in these civil spoofing cases is growing. I find it interesting to see the repeat offenders.
⬆️Spoofing - The Growing List of Civil Cases⬆️
— hoffmann6383 (@hoffmann6383) January 3, 2024
Recall the Defendant Broker-Dealer's statement on spoofing in $NWBO v. Citadel, et al, case No 1:22-cv-10185-GHW-GWG:
"This is bedrock market-making activity that the Securities and Exchange Commission has explained is an… pic.twitter.com/2sC2I8mBvj
Exactly right senti. The company won't PR validation. Most companies don't, as has already been pointed out. The reason most companies don't PR validation is spelled out here:
https://g.co/bard/share/eea27cc11ca7
People can point towards two convoluted emails to different people months apart for the proposition that nwbo stated they would PR validation, but that's a reach if I've ever seen one. Innes isn't going to tell us things that aren't public, i.e. whether nwbo will PR validation. It's illogical message board dot connecting where people are twisting words to hear what they want to hear.
Validation is complete. We won't see a PR. Pointless to continue this conversation further unless the goal is to purposely stir the pot. all imo
SUMMARY & THOUGHTS: Plaintiff's Limited Objection to Magistrate Judge Stein's Report and Recommendation Regarding the Element of Loss Causation
⚖️SUMMARY & THOUGHTS: Plaintiff's Limited Objection to Magistrate Judge Stein's Report and Recommendation Regarding the Element of Loss Causation⚖️$NWBO
— hoffmann6383 (@hoffmann6383) January 15, 2024
BACKGROUND
On December 29th, 2023 Magistrate Judge Stein issued his Report and Recommendation (R&R) on Defendant’s Motion… pic.twitter.com/Mt4OmokVlb
Objections to the Report and Recommendation by both parties are due today.
Congrats to you and CaptainObvious for your promotions to moderator.
And thanks to Dr. Bala & Happylibrarian for their years of work.
Interesting Dr. Mulholland testimony at the UK's Health Select Committee today.
💯%
— hoffmann6383 (@hoffmann6383) January 9, 2024
Wonder what Dr. Mulholland is referring to at the end when he states there are combination treatments available right now that give much better outcomes than the SoC for brain tumors?
Dr. Mulholland presented $NWBO's #DCVax-L topline data on May 10, 2022 at the New York… pic.twitter.com/wCOTDBaQ1V
great summary! thanks senti.
Flipper, thank you for providing the purported list of MAA validation PRs. I stand by my earlier comments found here. There are examples of MAA validation PRs (none of which are found below), but they pale in comparison to the numbers of companies that choose not to PR validation.
My comments to your list of purported MAA validation PRs is found below in red.
Only one of those examples involves a MAA validation PR. The rest are EMA or FDA. Again, no one is denying that there are companies that PR a MAA validation in the UK. Yet, those examples of MAA validation PRs pale in comparison to the number of companies that do not PR the validation.
Further, we have to take into consideration industry best practices. This is where I turned to Bard. Note, I'm not using selectively chosen responses from chatGPT, but instead posting the entire conversation with Bard. fyi - ChatGPT is only current through September of 2021 (unless you are using a paid version).
I have no idea if NWBO is going to PR validation and neither does anyone else. All we can do is guess, but based on past company behavior and industry best practices, the chances appear low for a MAA validation PR.
Edit: Flipper, if you could provide links to your statements. The first supposed validation on your list was no where to be found in the companies press releases: https://ir.imux.com/news-releases. Likewise, the 2nd link could not be validated at the companies PR page: https://www.pharming.com/news. Horizon was bought out so I skipped them. The fourth on the list is also missing this information in their press releases: https://ir.aeglea.com/press-releases/default.aspx. Anyways, please provide links. Thanks.
Question:
The term is validation (not acceptance) per the MHRA and based on a search of validation PRs, I believe the chance of NWBO PR'ing the validation of the MAA is low.
Notice how we already have members of the hedge fund social media army planting seeds that something is wrong because the company said they would PR validation.
Today's Report/Recommendation gives me even more confidence this case will be moving to discovery.
🧑⚖️Magistrate Judge Stein's MTD Report & Recommendation🧑⚖️
— hoffmann6383 (@hoffmann6383) December 29, 2023
The Case: $NWBO v. @citsecurities, et al, Case No 1:22-cv-10185-GHW-GWG
Recommendation & Report
"...the Court respectfully recommends that Defendant's motion be GRANTED due to the Plaintiff's failure to adequately plead… pic.twitter.com/wC7sC8vjqx
DCVax-L Submission Order
🇬🇧 -> 🇨🇦 -> 🇺🇸 -> 🇪🇺
MHRA Timeline (minus NICE)
Health Canada Timeline
^^ imo
Zadie: Canadian approval is fast. It's the price reimbursement for each providence that takes a while. Approval is 180 days accelerated.
Next steps with the MHRA:
1. Validation of the MAA
2. Assessment of the MAA
How long does each step take?
1. Validation - 4 days (mean) to 7 days (90%)
2. Assessment - trailing 12 month averages are largely below 150 days*
* Keep in mind this data includes review processes which are not accelerated. NWBO requested an accelerated review. Also, on the 2023 chart look at the dotted blue line (it's a very busy chart). Lastly, the 2023 chart excludes Orbis and Access Consortium. If you add those back in it actually increases the approval timeline.
Data:
➡️Mean Processing Time for Acceptance of MAA⬅️$NWBO
— hoffmann6383 (@hoffmann6383) December 26, 2023
MHRA MAA Acceptance Times
✅Mean = 4 days
✅90th percentile = 7 days
✅NWBO's MAA filed 12-20
4 (business) days = December 27th
7 (business) days = January 2nd
^^ Business days excluding Christmas/New Years
Expected… pic.twitter.com/CjkwHGZ1aK
➡️MHRA Validation & Approval Timelines⬅️$NWBO
— hoffmann6383 (@hoffmann6383) December 26, 2023
Validation Timeline:
See Prior Post. 4 days (mean) to 7 days (90%).
Approval Timeline:
2020 Time to Complete Assessment, New Marketing Authorisations - UK Only [1 & See Image 1]
2021 Time to Complete Assessment, New… https://t.co/KczzKK09i9 pic.twitter.com/x2QnYhnWlw
Great PR today.
RIP to my friends who lost the bet. Let's see if they keep to their word.
To my other friends that didn't have enough confidence to enter the bet but spewed the hedge fund company line on a daily basis, this one is for you.
➡️A Day in the Life of a $NWBO Shareholder ⬅️
— hoffmann6383 (@hoffmann6383) December 21, 2023
"No submission this year and maybe next year as well with these asshats." [1]
"I don't believe this mgmt will achieve submission." [1]
"Dead stock for 2023. Maybe submission by 2024? News 2025?" [2]
"There will be no submission in…
Submission Bet Summary
✅️ @flipper44
✅️ @hoffmann6383
✅️ @The Danish Dude
✅️ @CrashOverride
✅️ @Springbok80
^^ If there is no submission in 2023 then these posters will stop posting on ihub.
v.
✅️ @Maverick0408
✅️ @exwannabe
✅️ @underpar71
✅️ @Grip it and Sip It
✅️ @martyDg
✅️ @Jackxkr
✅️ @aesop1
❓️ @DrHigh
❓️ @churchill_21
❓️ @learningcurve2020
❓️ @Legend431
❓️ @iclight
❓️ @Poor Man -
🚫 @FeMike
🚫 @RobotDroid
🚫 @manibiotech
^^ Submission in 2023 then the posters that have accepted the bet in time will cease to post
✅️ = accepted bet
🚫 = declined bet
❓️ = have yet to answer
Thank you to all of those participating and I hope to hear an answer from a few of you!
Only providing the proof where I entered this bet to keep this post in line with the community guidelines:
Harrington's first MTD took 8-9ish months to decide. Harrington's 2nd MTD took four months to decide. We have a new judge. The judge's docket is largely filled with newer cases. The judge read all the briefings in preparation for the oral argument. We have recently decided case law. Considering all of this I'd guess that a ruling would happen in under 4 months. So call it between now and mid March. That being said, this is only a guess. I wouldn't be surprised one bit if it took longer.
Assuming the MTD is denied then we get into scheduling dates for discovery.
Should all-star fudster FeMike over on $NWBO's liehub page honor his word and stop posting?
— hoffmann6383 (@hoffmann6383) April 13, 2023
(screenshot to follow)
I believe KG was referring to the Hedge Fund side of Citadel in his interview comments. Our case involves the MM side of Citadel. Supposedly, two separate companies with a firewall between. We won't see anything with respect to an injunction until after the MTD decision, if even at that point. Permanent injunctions are often awarded at the end of the case.
NWBO is asking that Defendants stop spoofing. Defendants say they are not spoofing. Spoofing is already illegal. I've never dealt with this scenario where the request for a permanent injunction involves the ceasing of behavior that is already illegal.
To answer your question - I doubt it, but I'm not certain. If they are going for a temp injunction we will see more filings in that regard b/c the complaint only asks for a permanent injunction.
Ken Griffin claims that his firm's price setting benefits everyone - from the retail investor to the companies themselves. 🤥
➡️Kenneth C. Griffin v. Reality⬅️
— hoffmann6383 (@hoffmann6383) December 11, 2023
In this post I’ll apply Mr. Griffin’s comments in his recent David Rubenstein interview to the allegations found in a civil suit brought by $NWBO against seven separate broker-dealers, including @citsecurities, to determine if all relevant… pic.twitter.com/3brC7IKDZD
Submission Bet Summary
✅️ @flipper44
✅️ @hoffmann6383
✅️ @The Danish Dude
^^ If there is no submission in 2023 then these posters will stop posting on ihub.
v.
✅️ @Maverick0408
✅️ @exwannabe
✅️ @underpar71
✅️ @Grip it and Sip It
✅️ @martyDg
☑️ @DrHigh
✅️ @Jackxkr
👊 @churchill_21
✅️ @aesop1
👊 @FeMike
🚫 @RobotDroid
❓️ @learningcurve2020
👋 @Legend431
^^ if there is submission in '23 then these posters will stop posting on ihub.
@Grip it and Sip It, I accept your bet.
Submission Bet Summary
✅️ @flipper44
✅️ @hoffmann6383
^^ If there is no submission in 2023 then these posters will stop posting on ihub.
v.
✅️ @Maverick0408
✅️ @exwannabe
✅️ @underpar71
✅️ @Grip it and Sip It
✅️ @martyDg
☑️ @DrHigh
👊 @Jackxkr
👊 @churchill_21
👊 @aesop1
👊 @FeMike
👊 @RobotDroid
^^ if there is submission in '23 then these posters will stop posting on ihub.
@Grip it and Sip It, I accept your bet.
Hey GermanCol!
It's FDA approval data from 2011-2020.
$NWBO's chance of approval with a submitted BLA:
— hoffmann6383 (@hoffmann6383) February 2, 2023
9⃣8⃣.4⃣%
(Data from 2011-2020) pic.twitter.com/7rrz6x9VIK
➡️ $NWBO MAA Timelines & Progress Updates ⬅️
— hoffmann6383 (@hoffmann6383) November 22, 2023
I'll quickly go over the estimated MAA submission timelines and the incremental progress we have seen with the last three MAA PRs.
1⃣ 8-29-23 Press Releasehttps://t.co/FkWDynSCs4
Submission: September 28 to October 13
Progress:…