Replies to post #641423 on NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

pqr, the primary advantages of Project Orbis is:

(1) the Sponsor only has to complete 1 application. Then, that 1 application can be submitted to the MHRA, FDA, Health Canada, and other Participating Orbis Partners (POPs), and

(2) the submission application can be reviewed almost simultaneously by multiple regulatory authorities (RAs) at the same time.

However, each RA will make their own independent approval or denial decision, based on each RA’s own timetable and based on each RA’s own approval criteria.

[flipper44]

Advantages of using project Orbis.

Project Orbis is a collaborative initiative that aims to expedite the global development and review of promising cancer treatments. Some advantages of using Project Orbis include:

1. **Accelerated global access**: Project Orbis allows for concurrent submission and review of cancer treatments in multiple countries, potentially speeding up the process of getting innovative therapies to patients.

2. **Efficient regulatory collaboration**: By facilitating information sharing among international regulatory agencies, Project Orbis promotes efficient collaboration, enabling regulators to work together and share insights to accelerate the drug review process.

3. **Harmonized standards**: It promotes the development of harmonized standards for evaluating the safety and efficacy of cancer treatments across multiple countries, potentially streamlining the regulatory process.

4. **Improved patient access**: Through quicker approvals, Project Orbis may enhance patient access to potentially life-saving treatments, ensuring that patients in different countries can benefit from the latest advancements in cancer care simultaneously.

5. **Pooling of expertise**: The initiative enables regulatory authorities to pool their expertise, leading to a more comprehensive evaluation of treatment data, which can provide a more nuanced understanding of a drug's potential benefits and risks.

By combining the strengths of multiple regulatory agencies, Project Orbis fosters a more streamlined and collaborative approach to evaluating and approving cancer therapies, ultimately benefiting patients around the world. ChatGPT