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No, it is an exclusive deal.
10Q after market close today.
Sell off and spin off are two different things. When it is a spin off, the NWBO share holders also get new company's shares.
This will take care the complaint of on OTC exchange and shares manipulation if any naked shorts existed, and even legal shorts.
Spin-off DCVax-L to major exchange to unleash its potential, at same time NWBO got cash money to continue develop DCVax-D.
Can NWBO spin-off DCVax-L and IPO on Nasdaq or New York exchange after approved?
Today's closing price wasn't influenced by someone submitting a market order. Please don't make excuses for MMs' actions. It's purely a case of price manipulation, which happens every day.
Will BMR attend GTC conference?
When is the share holder meeting?
10K after hour today.
Why do you do "105,899 square meters * 105,899 square meters"? 105,899 square meters itself is already square meters.
The prototype machine has been successfully completed, and the optimization of the manufacturing process has been also finalized. The design has been frozen. This achievement often marks a significant milestone. (usually we will shout out to everyone)👍️ The focus has now shifted to the production machine manufacturing phase. The goal is to ensure that the products manufactured by the production machine align with those produced by the manual machine. Successful alignment will pave the way for certification.
Importantly, there are currently no known show-stopping issues. This signifies a positive outlook for the project, suggesting that the further development process will see a smooth path. Moving forward, I see the certification process for Flaskworks is much shorter, given the existing certification of the manual process with the benefits from the prior certification of many infrastructure components and the quality control system.
In today's conference call, Merck is open to acquisitions of up to $15 billion.
The reviewing process of the Publisher/QC term for the MAA submission project is on the project critical path, it is the last action item in determining the project's completion timeline. The PR indicates that this process is well underway and currently in its final stage.
The majority of the work on the key section of the MAA has been successfully completed and delivered to the publisher. The only outstanding task is for the consultant to finalize the remaining small portion of the key section and deliver it to the publisher. Assuming this can be accomplished within that 2-3 weeks/several weeks timeframe, the submission project does not seem to be significantly delayed. Although completion in November may be questionable, there is a high probability that it will be successfully concluded in December.
There seems to be no clear reasons for NWBO doing last two press releases, unless they were specifically requested by the BP. I think the BP is seeking NWBO's official commitment regarding the submission of the MAA in the near future, and wants Dr. LL to be part of NWBO's business and actively involved in the company's science and technology development before committing to NWBO with business investment.
I think the combo deal is coming and is coming soon, maybe even before the MAA submission, with upfront equity investment.
Unfortunately, when a settlement is reached, most of the time there will be a Non-Disclosure Agreement (NDA) signed, which prevents the plaintiffs from disclosing anything. This is a major incentive for the defendant to settle. In fact, they may even state that the defendant admits no wrongdoing in the settlement. Therefore, anyone else who wishes to pursue legal action against the defendant needs to have their own evidence. I believe this is a significant reason driving market participants (MMs) to settle.
It's important to remember that NWBO's primary focus is to advance cancer treatment technologies; it is not their responsibility to expose bad market practices. The Securities and Exchange Commission (SEC) is responsible for investigating and taking action against market misconduct.
By the way, you seem to have used 'plaintiffs' when I believe you meant 'defendants.'
JMPO
In a scenario where a big pharmaceutical (BP) company has a drug that, when used in combination with a small company's drug, produces significantly improved results compared to using the BP drug alone, there are several reasons why the BP company might be incentivized to pay upfront for the collaboration:
Access to Valuable Asset: The small company's drug is a critical component in achieving the dramatic improvements seen in combination. The BP company recognizes that access to this drug is essential for enhancing their own product's efficacy or market potential.
Competitive Advantage: The dramatic improvements seen in combination could provide the BP company with a significant competitive advantage in the market. By paying upfront for the collaboration, they secure their position as a leader in the field and gain a head start over competitors.
Market Potential: The improved results from the combination trial could lead to a larger market share and increased revenue for the BP company. Paying upfront to secure the collaboration could be seen as a strategic investment to tap into this potential.
Intellectual Property: If the small company's drug has unique intellectual property or proprietary technology, the BP company might pay upfront for the rights to use that technology exclusively or in combination with their own drug.
Regulatory Advantage: The combination trial results might provide a stronger case for regulatory approvals or a more favorable position during the regulatory process. This can speed up time to market and increase the chances of successful commercialization.
Risk Mitigation: Paying upfront could provide the BP company with greater control over the collaboration and mitigate risks associated with the small company potentially partnering with competitors.
Strategic Positioning: By paying upfront and forming a collaboration, the BP company demonstrates its commitment to the combination therapy's success, which can enhance its reputation and relationships within the industry.
When a big pharmaceutical company wants to collaborate with a small clinical stage biopharmaceutical company for a combination trial, the financial terms of the collaboration can vary based on the specifics of the agreement between the two parties. Payment terms, including upfront fees, can depend on various factors, such as the negotiation power of each party, the stage of development of the small company's product, the potential benefits of the combination trial, and the overall structure of the collaboration.
Here are a few possibilities regarding upfront fees:
Upfront Payment: The big pharmaceutical company may offer an upfront payment to the small company as a sign of commitment and to secure the collaboration. This payment could cover a variety of costs, such as access to the small company's product, expertise, or intellectual property. It might also reflect the value the small company brings to the partnership.
Equity Stake: Instead of an upfront payment, the big pharmaceutical company might offer the small company an equity stake in the form of shares or stock options. This allows the small company to share in the potential future success of the collaboration.
Milestone Payments: The collaboration agreement could involve milestone payments tied to specific achievements or events during the trial's progress, such as successful completion of certain stages, regulatory approvals, or reaching specific patient enrollment targets.
Royalties or Revenue Sharing: In some cases, the small company may agree to forgo upfront payment in exchange for a share of future revenues or royalties generated from the collaboration, particularly if the combination therapy proves successful.
In-Kind Support: Instead of direct financial compensation, the big pharmaceutical company might offer in-kind support, such as funding certain development costs, providing resources, or offering access to their expertise and capabilities.
How, from your IRA account to your Roth IRA account?
Have a partner
Karma is a bitch!
Let me try to explain,
I thought the DCVax was produced in the UCLA lab for the trial.
When you have your own manufacturing facility and contract out some work with CRL, you have reduced the risk and more leverage to negotiate the contract.
I believe it is a judgment call.
No, Just to check out $IBRX, how risky it is to go with CRL, a very promising BLA but failed with manufacturing issues. There are many cases like this. We need to control our own destiny.
SEC awards record $279 million to whistleblower
https://www.cnbc.com/2023/05/05/sec-record-whistleblower-award.html
Haha, weekend rate?
Once the excellent combo trial results are officially announced or confirmed (May 02 ?), it's difficult to imagine that BRK wouldn't take action on NWBO, as another party might seize this gem.
From ChatGPT:
The MAA application typically includes a comprehensive set of data and documents that provide evidence of the quality, safety, and efficacy of the medicinal product. The specific content of the application can vary depending on the type of product and the regulatory requirements of the country or region where the application is being submitted.
In general, the MAA application includes data and information related to the following aspects of the medicinal product:
1. Non-clinical studies: This includes data from studies conducted in animals or in vitro to evaluate the pharmacology, toxicology, and other relevant characteristics of the product.
2. Clinical studies: This includes data from the clinical trials conducted in humans to evaluate the safety and efficacy of the product.
3. Manufacturing and quality control: This includes information on the manufacturing process, quality control procedures, and specifications for the product.
4. Pharmacovigilance: This includes plans for monitoring and reporting adverse events associated with the product.
5. Labeling and product information: This includes the proposed labeling, product information, and other materials that will be provided to healthcare professionals and patients.
6. Regulatory and legal information: This includes information on the regulatory and legal status of the product, including any patents or exclusivity rights.
The TMF is a key part of the MAA application and includes all of the essential documents related to the conduct of the clinical trial, such as the protocol, investigator brochures, informed consent forms, and study reports.
The TMF is a collection of documents related to the clinical trial, and it is typically maintained by the sponsor of the trial. While the CRO may be responsible for managing and organizing the TMF on behalf of the sponsor, the contents of the TMF are ultimately the responsibility of the sponsor. The MAA application is also typically prepared by the sponsor, although they may work with a CRO or other service providers to gather and analyze the necessary data and documents. The specific contents of the MAA application can vary depending on the product and the regulatory requirements, but typically include information on the product's safety, efficacy, quality, manufacturing process, and proposed labeling.
What percentage of the company received MIA but did not receive MAA?
HAHAHA,
But I don't think ChatGPT will say that if there is no some truth in that.
ChatGPT
You are saying that Foxconn could worth more than Apple?
Another unfounded fear.
AF is so pissed off. Why drag me into this? I was just bullshitting about NWBO!
LMAO
Yes, diabetes1
Billion-dollar question: earlier this week, PFE bought SGEN for $42B. MRK dropped the same deal several months ago. Why did MRK drop the deal? Was SGEN not good enough for MRK? If it wasn't good enough for MRK, why was it good enough for PFE? Or did MRK find a better target? Why doesn't PFE go for that better target instead? Or has it already been secretly 'booked' by someone? I keep remembering that on ASM, LP mentioned that there are many activities behind the scenes that they have not/cannot talk about. I keep wondering what they are.
At the same time earlier this week, PRVB was also bought out. The stock price was at $6.75, and the buyout price was $25, almost 4x. Check out the stock price before the deal; it was down every single day until last Friday. Do you see a similarity somewhere else?
With good news continuing to come in, keep the faith!
No side effects, long survive rate = approval
Everything else is noise.
Is the MIA approval a prerequisite for MAA submission in England?
In the UK, a Manufacturing and Importation Authorisation (MIA) is required for companies that manufacture, import, or distribute medicinal products. The MIA is issued by the MHRA and is a prerequisite for the submission of an MAA.
The MIA demonstrates that the manufacturer has appropriate quality control systems and procedures in place to ensure that their products are manufactured to the required standards. It also includes information on the facilities, personnel, and equipment used in the manufacturing process.
So, in short, a valid MIA is a prerequisite for submitting an MAA in the UK, as it confirms that the manufacturer has the necessary certification to produce medicinal products according to the required standards.
Is MAA submission a prerequisite for the MIA approval?
No, in the UK, submitting a Marketing Authorisation Application (MAA) is not a prerequisite for obtaining a Manufacturing and Importation Authorisation (MIA).
An MIA is required for companies that manufacture, import, or distribute medicinal products. The MIA confirms that the manufacturer has appropriate quality control systems and procedures in place to ensure that their products are manufactured to the required standards. It also includes information on the facilities, personnel, and equipment used in the manufacturing process.
On the other hand, an MAA is required to gain marketing authorization for a new medicinal product in the UK. The MAA demonstrates that the product meets the necessary safety, efficacy, and quality standards for use in humans.
So, the MIA is a prerequisite for manufacturing and distributing medicinal products in the UK, while the MAA is a prerequisite for marketing a new medicinal product in the UK.
MIA approval requires MAA is in the process, what does that mean in the process, does that mean the submission?
You are correct that in the UK, a Marketing Authorisation Application (MAA) needs to be in progress or submitted for an applicant to be granted a Manufacturing and Importation Authorization (MIA).
"In the process" generally means that the applicant has started the MAA submission process with the Medicines and Healthcare products Regulatory Agency (MHRA), which is the UK's regulatory agency responsible for assessing and authorizing medicines. Typically, the MHRA will review the MAA and inspect the manufacturing facility before granting the MIA.
Therefore, to obtain an MIA, the applicant needs to demonstrate that they have an ongoing MAA submission process with the MHRA, which can involve submitting the application, providing additional information, and responding to any questions or requests from the agency. Once the MAA is deemed acceptable by the MHRA, the agency can then proceed with the inspection of the manufacturing facility and the granting of the MIA.
Sorry I am at different field, no knowledge of the rest of steps, I think will be same as manual production approval process.
But my opinion is that this internal validation is very significant, it should make everyone working on it have a good sleep.
Based on the ASM, Flaskworks process is validated, it can produce vaccine with same results as the manual process vaccine, even at different production rate.
What that means, it means that technically Flaskworks does not have any show stop issues, it is verified and good to go, although before it is certified there are still many formality steps need to go through.
Do we have several here?