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You are correct Override but here is some ChatGPT food for thought:
If a company develops a platform technology that is proven to be effective across multiple tumor types (tumor-agnostic therapy) and submits it for FDA approval, the Payment of PDUFA fees can vary depending on the type of application and the specific circumstances. Typically, each application for a new drug or biologic would require its own PDUFA fee. However, if a therapy is approved under a broad indication that encompasses multiple tumor types based on a common biomarker or mechanism of action, it might potentially reduce the need for separate applications and fees for each tumor type.
In practice, the FDA may evaluate the submission based on the clinical evidence and the proposed indication(s) for use. If the therapy demonstrates efficacy across multiple tumor types under a single indication, the company may seek approval for that broader indication, potentially streamlining the regulatory process and associated fees.
Ultimately, the determination of PDUFA fees and regulatory pathways would depend on the specifics of the therapy, its intended use, and how it aligns with current FDA guidelines and policies for tumor-agnostic therapies.
NICE appraisal page for NWBO is down. https://x.com/peter_brit/status/1792441297980076337?s=46&t=eKWlfJ_s47ckE6GTsb7D0w
Steady_T,
After a deeper look, I think you are correct.
ChatGPT:
The distinction between "acceptance" and "validation" in regulatory terms often hinges on what each step represents in the process:
1. **Acceptance**: This is when the regulatory body initially receives and acknowledges the application. It’s more about confirming that the submission has been received rather than assessing its content.
2. **Validation**: This step goes beyond mere acceptance by checking that all required documents, data, and components are included and meet the criteria set out by the regulatory body. This ensures that the application is not only complete but also organized according to specific regulatory standards.
Starting the review clock at validation rather than acceptance allows the regulatory authority to ensure that the application is truly review-ready and minimizes the risk of significant delays due to missing or incorrect information. If the clock started at acceptance, there could be potential delays right after if the application were found to be incomplete upon initial review. Therefore, starting the clock post-validation promotes a more efficient and effective review process.
Furthermore:
If your Annual Shareholder Meeting (ASM) is by the end of June, and the 150-day assessment phase started on January 24, 2024, the timeline calculation remains essentially the same with the phase concluding around June 23, 2024. This gives a slight buffer between the end of the assessment phase and your ASM. Here’s how this affects planning and expectations:
1. **Completion of Assessment**: With the assessment phase ending just before the ASM, this allows a few days for final preparations or to address any last-minute details or communications from the regulatory body.
2. **RFI Considerations**: As mentioned earlier, RFIs can still be issued during the assessment period. The timing of any RFIs, and the company’s ability to respond effectively, will be crucial. If RFIs are issued later in the phase, they could extend the review process, potentially impacting the information available at the ASM.
3. **Preparing for ASM**: It’s wise to prepare for the ASM with scenarios in mind that may include the latest regulatory status. Depending on how the assessment goes, you might need to inform shareholders about a successful completion or discuss potential delays and their implications.
4. **Communication Strategy**: Have a communication strategy ready for different outcomes from the regulatory review. This includes being prepared to discuss any RFIs received, how they were addressed, and their impact on the review timeline.
This slightly extended timeframe between the end of the assessment phase and the ASM provides a cushion that might be useful in managing last-minute regulatory communications or decisions.
May 19th.
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…
This is why $NWBO is quiet pic.twitter.com/mJ50JlTIAM
— Andrew Caravello, DO (@andrewcaravello) May 10, 2024
ChatGPT Answer:
“Determining the "hardest to treat" cancer can be complex because it depends on various factors, including the stage at which the cancer is diagnosed, its type and location, genetic mutations, and how it responds to treatment. However, some cancers are notoriously difficult to treat due to their aggressive nature, tendency to be diagnosed at a late stage, and resistance to current therapies. These include:
1. Pancreatic Cancer: Often diagnosed at a late stage because early-stage pancreatic cancer rarely causes symptoms. It's also known for its resistance to chemotherapy and rapid progression.
2. Glioblastoma (a type of brain cancer): Highly aggressive and known for its poor prognosis. Treatment options are limited because the blood-brain barrier restricts many types of chemotherapy from entering the brain tissue.
3. Lung Cancer: Especially small cell lung cancer, which is aggressive and tends to spread quickly. It's often diagnosed in advanced stages.
4. Liver Cancer: Hepatocellular carcinoma, the most common type of liver cancer, is particularly challenging to treat, especially in cases where the liver is already damaged by diseases such as hepatitis or alcohol abuse.
5. Triple-Negative Breast Cancer: Lacks the three receptors known to fuel most breast cancer growth—estrogen, progesterone, and the HER-2/neu gene—making it resistant to some of the most effective therapies.
These cancers are challenging due to their complexity, aggressiveness, and the body's critical functions they affect, making safe and effective treatment difficult. However, research is ongoing, and advancements in personalized medicine, immunotherapy, and targeted therapy continue to provide hope for better treatments and outcomes.”
That was my first thought when I watched the video. Seems like it would be a synergistic relationship. Market would be cornered.
Excellent observation Doc logic. Paid shills are digging themselves deeper. Will get demoted for this one lol.
LOL, keep watching... NWBO hitting NYSE might just be the wake-up call from your skepticism. Pink sheet to prime time, let's bet on it
Calender days
I was thinking the same thing. SMH
Given the magnitude of what might be uncovered, do you think this might push towards a settlement to avoid airing out such specifics publicly?
Charm flagged as spam? Must've hit the mark.
Ah, before you call it a hoax, swap that pitchfork for a pen and learn from those actually in the fight. Knowledge beats noise, every time.
https://www.investorvillage.com/smbd.asp?mb=445&mn=25514&pt=msg&mid=1288319
You don’t say?
The End Brain Cancer Initiative (EBCI) is advocating for FDA approval of DCVax-L®, a novel treatment for Glioblastoma (GBM) brain tumors, in anticipation of submittal of the application for FDA approval by Northwest Biotherapeutics. Read Press Release: https://t.co/XXK0z03dJV. pic.twitter.com/bBIk9LR33V
— EndBrainCancer Initiative (@EndBrainCancer) February 28, 2024
Email Sue Goldman - sue@nwbio.com
She responds quickly.
So, we're playing the 'a caterpillar can't flutter' game, are we? Wise investors know that in the garden of innovative cancer therapies, patience isn't just a virtue—it's the cocoon from which breakthrough butterflies emerge. Just wait until those DCVax wings unfold.
Tell us how you really feel 😂
I share your sentiment. Also, thanks, I’m a big Pearl Jam fan
So 80 days? March 10
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines
“New active substances and biosimilar products
The assessment process includes consultation with the CHM on fixed dates each month. The submission slots will be linked to the dates of CHM meetings. The MHRA may additionally wish to seek advice or input from therapy area experts (specialty expert groups) during the assessment process.
The assessment process will run in two phases totalling 150 days with an intervening clock-off period between phase I and phase II, if required. Assessment phase I will be completed 80 days after the clock starts. Issues arising or requiring clarification from the initial assessment will be raised with the applicant as a letter requesting further information (RFI) and should be addressed within the clock off period of 60 days.
Requests for extension of the clock off period for up to another 60 days may be granted only for exceptions. Applicants may contact the assessment team for discussing issues raised in the RFI letter. Assessment in phase-I will also address eligibility for grant of orphan status. Phase II assessment will commence on receipt of the applicant’s responses. Applicants are recommended to contact the MHRA Assessment Team in advance of the intended date of submission of response to align with CHM meetings. Based on the assessment, the MHRA will provide a decision on approvability of the product by day 150.
For new active substances and biosimilar products the orphan status will be determined at the time of MA grant. If orphan status is not agreed and the company wishes to appeal this decision, the grant of a marketing authorisation will only be possible when the appeal process is completed.”