NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

J-To,

Thanks for asking. Some technologies take a few years and some take many—the range is vast. This is the quote that is most directly relevant, in my opinion: “The first checkpoint inhibitor, ipilimumab, was approved by the FDA in 2011, but the foundational research dates back to the 1980s and 1990s.”

“The development and approval of new medical technologies, particularly those requiring regulatory approval, typically span several years or even decades, largely due to the stringent safety and efficacy standards set by regulatory bodies.

1. **Research and Development Phase**: This initial phase involves basic research and preclinical trials. For medical technologies, this stage is crucial for understanding the underlying mechanisms and potential applications. It can take several years, depending on the complexity of the technology.

2. **Clinical Trials**: Once preclinical trials indicate potential efficacy and safety, the technology enters clinical trials, which are often divided into three phases (I, II, and III). Each phase progressively involves more participants and focuses on safety, efficacy, and dosage. Clinical trials for medical technologies can take several years to more than a decade, depending on the trial results, participant recruitment, and the nature of the technology.

3. **Regulatory Review and Approval**: After successful clinical trials, the technology requires approval from regulatory bodies like the FDA (U.S. Food and Drug Administration). This process involves a thorough review of the clinical trial data and can take additional years.

4. **Post-Market Surveillance**: Even after approval, most medical technologies are subject to ongoing monitoring for long-term safety and effectiveness.

For instance, consider checkpoint inhibitors, a class of drugs that revolutionized cancer treatment. These drugs, which enhance the immune system's ability to fight cancer, underwent extensive research and development. The first checkpoint inhibitor, ipilimumab, was approved by the FDA in 2011, but the foundational research dates back to the 1980s and 1990s. This timeline reflects the years of preclinical studies, clinical trials across several phases, and the time taken for regulatory review and approval.

In summary, the development and regulatory approval of medical technologies like checkpoint inhibitors is a lengthy, multi-stage process involving extensive research, clinical trials, and regulatory scrutiny to ensure safety and efficacy.”

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-that-a-marketing-authorization-application-has-been-submitted-to-the-uk-mhra-for-dcvax-l-for-glioblastoma-302021038.html