NorthWest Biotherapeutics Inc (NWBO)

[The Danish Dude]

Question to ChatGBT

How much has MHRA guided NWBO since pim designation of dcvax-l in 2014? Can you research MHRAs role during the last decade regarding licenses, applications and compassionate use as well as look into this fast track in terms of how it could relate to DCVax-L

https://www.gov.uk/government/news/mhra-to-receive-10m-from-hm-treasury-to-fast-track-patient-access-to-cutting-edge-medical-products

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Since its designation as a Promising Innovative Medicine (PIM) in 2014, DCVax-L, developed by Northwest Biotherapeutics Inc (NW Bio), has been significantly guided by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. The PIM designation marked DCVax-L as an innovative cell therapy for cancer, specifically targeting all malignant gliomas, including Glioblastoma multiforme, the most severe grade. This designation was the first step in the Early Access to Medicines Scheme (EAMS), aimed at expediting patient access to medicines where there is a significant unmet medical need.

The MHRA's role in this process is crucial. To receive a PIM designation, a company must demonstrate that the condition treated by the product is life-threatening or seriously debilitating with a high unmet need. Additionally, the product should offer a major advantage over existing treatments, and any potential adverse effects should be outweighed by the benefits. The MHRA rigorously scrutinizes the preliminary scientific evidence during this assessment.

Following the PIM designation, NW Bio continued to develop DCVax-L, and if proven effective in trials, it could apply for step II of the EAMS. This would allow patients to benefit from the therapy while the company generates further data to understand how the drug works. Eventually, the product would undergo formal medicines licensing.

The EAMS, launched in April 2014, has a three-step process. After the initial PIM designation, the product undergoes further evaluation of its risk/benefit and manufacturing consistency. If successful, it must be approved by the NHS commissioning board. This process aims to provide urgently needed drug therapies to patients more quickly, similar to the compassionate use program in the U.S.

DCVax-L's designation and subsequent development under the EAMS reflect the MHRA's ongoing commitment to fostering innovation in life sciences, especially for conditions with limited treatment options. This case illustrates the MHRA's role in facilitating the development and early access to innovative medical treatments over the past decade

MHRA have been cooperating with NWBO since 2014 and digging deeper, they have cleared the path for fast approval and continue to do so with the new fast track funding specifically worded at cancer vaccines within next 2 years.

There will be no delays and approval will hit swiftly and with style.