In May 2022 the stock price reached 2.2 in December 2022 it was at 1.2. During those periods of time, it was well known and you were very well aware that NWBO for a large part funded Advent. Why didn't you sell then if it bothered you so much? Why do you keep whining about Advent here?
It bothered me when I first learned Advent is not an NWBO subsidiary, which yes it should have, but I stopped complaining about it long ago and reconciled with that fait accompli. Why do you keep on whining about Advent not being an NWBO subsidiary while the tens of billions of value will be in NWBO and not Advent? What other reason is there for you to complain like an aggrieved toddler month in and month out other than your own statement you want to destroy NWBO? If you had discussed the relationship between NWBO and Advent in 10 posts max and moved on you would have been much more believable as an NWBO long.

For me, its very clear as daylight you are no financial consultant. You have little knowledge of investing other than taking short positions

what makes you think I give a shit what you screenshot. Try another come back better yet leave in shame.

and more thing mr KF, other than the Florida Judicial Court allowing the discovery to determine your real identity in the case of US Stem Cell, what convinced me as well of your ill intentions. Using the term "retard" all the time by you as a sobriquet is a sickening offensive to our fellow citizens and human beings who are so unfortunate of being hindered by mentally less capacity than other people.

My sister works with people who are mentally incapacitated you feel the need to poke and denigrate. Shame on you

screenshot the hell out this

https://www.youtube.com/shorts/-JC62GH77-0

you are so naive its adorable lol

no thanks I decline your offer but keep promoting your business here perhaps you will find other clients

whatever you lost any credibility years ago flip flop. You are just an entertaining joke of the week.

Nope did not make that up. Unlike you have an excellent network.

If you think management including Linda Powers will not provide information that is not available for regular shareholders, under NDA or not, then you are very naive.

If I didnt have that specific network of info I would already have sold years ago..

Thermo will only tell us what he heard from management. Thermo's timelines have been wrong because management's timelines are wrong and thus the info he receives is wrong. He doesnt make timelines up.

They will PR after the submitted application has been accepted:)

Yes you are right. And I have that info from my friend who is in regular contact with management

Im expecting NWBO to cease and exist in 2024 after it has been acquired

NWBO is not a growth stock, NWBO investment is a binary zero-sum game. The binary is in the approval yes no + cash influx yes no. As soon as there the news is that NWBO has received approval and thus its product can be commercialized and even better has received a good amount of cash influx then the SP will shoot up and never look back.

If you want to invest in a typical assured growth stock NWBO is NOT your cup of tea better stocks are Microsoft, Merck, BMY etc

No argument there. Im just saying that the best liars are those that can tell the truth 35% of the time

ooh additional modules did Chat GTP tell you that NWBO was asked for additional modules?

Im telling you the same as I have told ex in my years of battle with him when it comes to FDA regulation (which I happen to thrive at). ADD A FDA PAGE AS A SOURCE TO STAKE YOUR CLAIMS. Understand? CHATGTP is NOT a reliable source if you add a "quote". Never been to college? In college, they teach you that stuff.

So This: "This guidance presents the agreed-upon common format that will be accepted in the ICH regulatory regions for the preparation of a well-structured Efficacy section of the CTD." Is from the EMA here https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m4-r4-common-technical-document-ctd-registration-pharmaceuticals-human-use_en.pdf
Ist is not from the FDA

Now that quote is NOT about the NUMBER of modules but about the "agreed upon common format" Do you understand the difference between the agreed-upon common format and NUMBER of modules?

I have never heard about the FDA's requestion additional MODULES. It does not exist
But by all means, ask ChatGTP

Not everything that ex is saying is nonsens. That makes him one of the annoying bears here
But he is helped by some very stupid pumpers longs posting incredible dumb shit with chatGTP as a source

I hate to say it but you are right.

Unfortunately, the obvious pump lies here drives away many honest longs

according to ATL this FDA website page is BS. According to ATL this FDA page is a lie:

LMAO
***************************

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m4er2-ctd-efficacy
M4E(R2): The CTD – Efficacy JULY 2017

https://www.fda.gov/media/93569/download

Docket Number:
FDA-2015-D-3235
Issued by:
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
This is one in a series of guidances that provide recommendations for applicants preparing the Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) for submission to the U.S. Food and Drug Administration (FDA or Agency). A common format for technical documentation significantly reduces the time and resources needed to compile applications for registration of human pharmaceuticals by eliminating the need for applicants to reformat data and information for submission to multiple regulatory authorities. This harmonization facilitates regulatory reviews, efficient communication between regulators and applicants, as well as the efficient exchange of information between regulatory authorities.

Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-D-3235.

1. You should provide a little bit more evidence than you silly ChatGTP with a wrong question ATL.
Why dont you add a link to the FDA manual providing your 7number of modules? Step up and provide accurate guidance link to the FDA with present Guidance for Industry CTD with your 7 modules then where is it?

2. You are accusing the FDA of gross neglect to have that guidance still online

3. This link leads to a page with the date JULY 2017 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m4er2-ctd-efficacy where this link is added by the FDA
https://www.fda.gov/media/71610/download which is the Guidance to 5 modules
Its irrelevant that Guidance dates from 2001 since tits the FDA and not mr ATL or ChatGTP that determines what documentation is still valid and relevant and which documentation is not. And the FDA is telling the industry on that page with the link to the guidance, the guidance with the 5 modules is still relevant.

But keep playing ignorant. Email the FDA to remove this link https://www.fda.gov/media/71610/download Im sure they will listen to you LMAO

Time and again I have proven you wrong. Your understanding of how biotech approval works is NIHL and Zilch

Your ignorance is mind-boggling. You are now contradicting FDA website pages. Un freaking believable how the lying of the Zealots have taken a turn.

You should provide a little bit more evidence than you silly ChatGTP with a wrong question ATL.
Why dont you add a link to the FDA manual providing your 7number of modules?

Also isn't it a little bit convenient to call the FDA guidance to the modules that need to be submitted outdated but ignoring the fact that the FDA still has this online and refers to the manual for the CTD Guidance for the Industry? You are accusing the FDA of gross neglect to have that guidance still online.

Step up and provide accurate guidance link to the FDA with present Guidance for Industry CTD with your 7 modules then where is it? ChatGTP now super proceeds the FDA website hahaha

Ooh and BTW its not 2002 its JULY 2017 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m4er2-ctd-efficacy

M4E(R2): The CTD – Efficacy JULY 2017

ChatGTP LMAO. Is that how you got your 1.7 Trillion valuation, asking ChatGTP?

Nice try tough mr ChatGTP

If you want to conduct into serious opposition based on fact-found sources fine by me welcome, Im not a crybaby who can't handle the truth like some zealots here.

But leave your stupid toddler jokes Im in no freaking mood.

facts are facts and it is correct NWBO needs EMA PIP first to submit a request for Marketing Approval with the EMA. However, it looks like the EMA grants a PIP waiver IF a PIP is approved by the MHRA. But Im not 100% sure of this. I have an answer later this week

https://www.gmp-compliance.org/gmp-news/mhra-announces-cooperation-with-seven-international-partners

The number of modules that need to be submitted to the FDA when submitting a BLA are 5 not 7. You can find them here

https://www.fda.gov/media/71610/download

This is one in a series of guidances that provide recommendations for applicants preparing the
Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) for
submission to the U.S. Food and Drug Administration (FDA). This guidance presents the agreed
upon common format for the preparation of a well-structured Efficacy section of the CTD for
applications that will be submitted to regulatory authorities.

Module 1. Administrative Information and Prescribing Information
This module should contain documents specific to each region; for example, application
forms or the proposed label for use in the region.
Module 2. Common Technical Document Summaries. Module 2 should begin with a general introduction to the pharmaceutical, including its
pharmacologic class, mode of action, and proposed clinical use.
Module 3. Quality
Information on Quality should be presented in the structured format described in the
guidance M4Q.
Module 4. Nonclinical Study Reports
The Nonclinical Study Reports should be presented in the order described in the guidance
Module 5. Clinical Study Reports
The human study reports and related information should be presented in the order
described in the guidance M4E


Thats what you get when you leave your DD to ChatGTP and on top of that ask the wrong question.

ChatGTP? This is the answer I got from ChatGTP when asking

how many core modules need to be provided to the FDA when submitting a BLA for cancer treatment

ChatGPT
As of my last update in September 2021, when submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a cancer treatment, there is no fixed or specific number of core modules that must be provided. The submission requirements and content for a BLA are quite comprehensive and are outlined in the Common Technical Document (CTD) format.

The CTD consists of five modules (Module 1 to Module 5), and each module contains specific sections of information related to the drug product. The content of each module varies depending on the type of product and the specific data available for the drug. The submission typically includes detailed information on the drug substance, drug product, preclinical studies, clinical trials, manufacturing processes, safety data, and more.

The FDA provides detailed guidance on the format and content of the BLA submission in various documents and guidelines, such as the "Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Content of Labeling" and the "Common Technical Document for the Registration of Pharmaceuticals for Human Use" guidelines.

However, please keep in mind that regulatory guidelines and requirements may evolve over time, so it's essential to refer to the most up-to-date guidance documents from the FDA or consult with regulatory experts when preparing a BLA submission for a cancer treatment.

c

as I have been saying

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171770904

Tuesday, April 25, 2023 3:03:34 PM
Its ILAP...

its NOT possible to request marketing approval for a cancer drug in Germany. All will have to go through EMA Amsterdam The Netherlands. Once the EMA has approved a cancer treatment it will be valid for all 27 member states.

Moreover, if it would be possible to request marketing approval for cancer treatment in Germany then requesting approval with the EMA would be redundant for the right to sell in one EU member state means also the right to sell that product in the other. Also, the EMA will grant approval for all EU member states including Germany not just the EU minus Germany.

exactly. And thats why I think after MHRA approval or MAA acceptance we will see an acquiring party invest a few hundred (2, perhaps max 3) million USD in NWBO, SP rises, uplist, FDA/MHRA approval, market cap around $13 billion buy out at $22 billion

completely deranged. detached from all reality, absorbed in fanatic nutcase drool, loony tunes.

Even Linda Powers with piss her panties all weekend if she would read this crap.

NWBO will be sold for around $ 21B and that will be the end of it, but I will sell at around $ 5-$8 never to look back.

I have quit arguing with the loony tunes long ago PM. You cant cure crazy. Just leave the nutcases be. After MHRA sell at $3 or $4 and move on.

Best advice I can give you

PM arguing with the Looney Tunes lol

"You can see an eventual valuation of over $1.73 trillion, which equates to $1,083.75 per share,""
Didnt you know NWBO will be worth 1.7 trillion USD soon, Apple eat your heart out
hahahahhahah lol hhihihihi pissing my pants here


$10 95% of all shareholders would sell

I think Les said in his radio show they are working on applicationS. Also I believe they will be submitting via project Orbis which would require more pages.

We will know between now and 3 weeks (is what i heard)

https://www.gov.uk/guidance/guidance-on-project-orbis

I have not glossed over anything. With Bigger threatening to become an activist investor if NWBO management does not change its course he has already become an activist investor.

As you perhaps know Twitter is a public forum. Bigger being vocal on a public forum telling NWBO management to change course IS textbook activism.

If NWBO in the past and present had already used the neoantigen database as an AI treasure trove to unlock the value he would not have Tweeted the threat that he Tweeted THUS he wants NWBO management to change the way it runs the company. Textbook activism.