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Every day is one ddd sad y closer to having NOT hear you complaining about this company and its management. I have to wonder what accomplishments you have achieved in your business life. Given what this company has achieved and considering the obstacles they have had to endure, I’m not sure anyone could have done a better job. Right now it’s up to the MHRA to complete its analysis. If it’s takes additional time I’m okay with that. Better they are thorough then to have the naysayers they did an incomplete job.
This is a post on X from Dr. Zivic:
Les told a friend at the ASM that the “fall” comment was a misstatement. He says he meant that by late fall all the things they’ve put together will make this a completely different company when they all fall into place. He didn’t mean to refer to MAA approval.
MHRA today told me start date for the #DCVax-L 150-day assessment started on January 24, 2024. 150 days = June 22, 2024. Obviously, this is only a target, not a mandate.
— rj (@sharpie510) June 27, 2024
Any day now.
🤞
LET'S GO $NWBO!
💪
The DCVax® Platform For All Solid Tumor Cancers#Glioblastoma #GBM #Hope pic.twitter.com/skMF65KHhG
Looks like ASCM is trying hard to keep the sp from rising.
Regarding the 150-day review clock for the MHRA, it typically begins once the (MAA) is validated. For NWBO, this validation occurred on January 23, 2024. Therefore, the review period would commence from that date, leading to an anticipated decision by June 21, 2024
— Kauri Capital (@KauriCapital) June 12, 2024
It was posted by Kauri Capital on 6/12/24
From a post on X.
Regarding the 150-day review clock for the MHRA, it typically begins once the (MAA) is validated. For NWBO, this validation occurred on January 23, 2024. Therefore, the review period would commence from that date, leading to an anticipated decision by June 21, 2024. This is one week prior to the ASM.
Thank you for your email, the 150 calendar days.
Please accept our apology for the late reply.
Kind regards
Ibrahim
MHRA Customer Experience Centre
Communications and engagement team
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000
gov.uk/mhra
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-----Original Message-----
Sent: Saturday, April 27, 2024 1:47 PM
To: ACCESS-MHRA
Subject: MAA APPROVAL
Can you tell me if the 150 day timeline for MAA approval is counted as calendar days or working days?
I wasn’t able to upload the screenshot but I included the link at the bottom of my post.
I looked on the MHRA website to see if the NWBO MAA was listed. As you can see from the above screenshot, drugs approved between 1 May to 14 May were announced on May 23. Conversely, approvals issued between 15 April and 30 April were announced on May 10. I believe applications approved between 15 May to 30 May will be announced on June 10. Those approved between 1June to 14 June will be announced on June 23. Sounds like the logic to have an ASM meeting on June 29. The link is www.gov.uk. In the search box type in Marketing Authorizations granted in 2024.
WRT= With respect to…
ChatGPT interpretation:
The information you've received regarding the expedited review process by the MHRA (Medicines and Healthcare products Regulatory Agency) involves key steps in the review of a Marketing Authorization Application (MAA). Here's what these notifications mean:
1. **"On January 24, 2024, the Company received notification from the MHRA that the MAA had passed validation."**
- This means that on January 24, the MHRA confirmed that the MAA submitted by the company was complete and met the necessary standards for regulatory review. Passing validation is the first major checkpoint in the regulatory process, indicating that the application is administratively and technically sound enough for substantive review.
2. **"On March 7, 2024, the Company received notification from the MHRA that the validation was confirmed."**
- This notification seems to reiterate or confirm the previous validation. It might indicate that any further necessary clarifications or adjustments requested by the MHRA post the initial validation were successfully addressed, reaffirming that the application remains valid and under review.
Regarding the 150-day expedited review clock that started on December 20, 2024:
- The expedited review process is designed to speed up the assessment of medicines that address unmet medical needs or are of significant importance. The clock starting on December 20 suggests that this is the formal beginning of the regulatory review timeline.
- With this timeline, you can expect that the MHRA aims to complete their review by approximately May 19, 2025, unless there are pauses in the clock for requests for additional information or other procedural reasons.
These steps are critical in the pathway to potentially obtaining marketing authorization for a new therapeutic product in the UK.
ChatGPT interpretation:
— Andrew Caravello, DO (@andrewcaravello) May 10, 2024
The information you've received regarding the expedited review process by the MHRA (Medicines and Healthcare products Regulatory Agency) involves key steps in the review of a Marketing Authorization Application (MAA). Here's what these notifications…
Suddenly inquirig and Nemisis have gone dark-thank goodness
When a company issues additional shares of stock, those shares are typically included in the total shares traded for that day. Shares traded refers to the total volume of shares bought and sold on a given trading day, including both existing shares and any newly issued shares.
The MHRA (Medicines and Healthcare products Regulatory Agency) approval schedules for Marketing Authorization Applications (MAA) are typically counted in calendar days, not working days. This means that the timeline for MAA approval includes weekends and public holidays, along with regular business days.
However, it's essential to note that the actual approval process can vary depending on several factors, including the complexity of the application, the completeness of the submitted data, the need for additional information or clarifications, and the workload of the regulatory agency. As a result, the time taken for MHRA MAA approvals can sometimes extend beyond the initial estimated timeline.
Agreed.
I know their motives but the amount of information is crazy. It’s hard to read through all the false information.
I checked the MHRA website for the Facts. Something you seem to ignore
When pontificating.
The Medicines and Healthcare products Regulatory Agency (MHRA) typically counts calendar days, not just business days, when evaluating and approving medicines or medical devices within a specified timeframe like 150 days. This means weekends and holidays are also included in the calculation. However, for precise details regarding specific processes or cases, it's recommended to consult official MHRA guidelines or directly reach out to the MHRA for clarification.
Keep talking. As you opine about the dangers of this stock, the price continues to rise. I’m glad I bought a few more shares last week. Good job!!
The more you try the more I buy.
It’s also possible they want to time the ASM with the MAA approval and/or with some other news on projects they are currently working. I’m sure they want to catch the shorts by surprise. Why telegraph their activities?
The definition of a franchise according to Chat GPT:
A franchise is a business model in which the owner (franchisor) grants a license to a third party (franchisee) to operate a business using the franchisor's branding, systems, and support. In exchange for the rights to operate under the franchisor's brand and business model, the franchisee typically pays an initial fee and ongoing royalties or fees. This arrangement allows the franchisee to benefit from the established brand recognition, marketing support, operational guidelines, and sometimes exclusive territories provided by the franchisor.
Correct. I in my post, I meant to say it would be a $25 billion selling price not a $25 share price. That represents a share price of about $14.75. Sorry for the error.
Your 25 to 1 equates to an $8 billion selling price. I think that would be low by any calculation.
If they value the sale at $25 billion I outlined what a potential stock deal could look like. Merck is not buying a $.60 stock. They would be buying a company that owns the technology that will change the cancer treatment world for the next 20 years to come. That’s not a bad deal for them and they wouldn’t be betting the ranch on the deal. Most likely it would be a cash/ stock deal IMO.
If Smitty is correct, and $15 is the sale price, then it’s possible for Merck to structure a deal to issue 1 share of MRK in exchange for 8 shares of NWBO. This would be equivalent to $25/sh sale.
Well said!
Blocked!
Maybe they are keeping it as a surprise!
Maybe everyone should take a deep breath and spend just a few minutes to watch thi you tube link :
https://www.youtube.com/c/CharlotteEades
Maybe , just maybe it will help you to realize what NWBO is trying to conquer and why many of us are here not only for the gains we hope to receive but the help this vaccine provides to patients
Good point!!
$.822455. Do you think we can get a few more decimal points??
Measure twice-cut once. I really don’t care if hit takes more time than they expected. What I care about is that they spend the time to put out a package that the MHRA is compelled to approve. Once approved I expect other regulatory agencies won’t be far behind.
Have you considered that you set deadlines based on the information you have at the time? Having run a large international company I realize the information changes all the time. Do you feel it would have been better if they decided to submit a package that was incomplete just so they said they met their deadline?
So did I. I see this as an opportunity.
I just got a call asking me if I was interested in loaning out my shares. I emphatically told the NO! I guess it’s just not Schwab sending emails and making calls.
$.975/share with 4.9 million traded as of 3:00 pm