NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Exactly—nGBM and rGBM require approval of the DCVax-L technology.

Reading the commentary of even the most critical naysayers, the most logical inference that we can draw is that they’re making the case for phase 4.

Generally, all drugs are effectively under some kind of phase 4-like scrutiny following commercialization, or they should be. Pembrolizumab is always a good example— safety, efficacy, and combo data have continued to be gathered and analyzed for years and years following its original approval.

Some further commentary from an AI app:

“A Phase 4 study in the context of drug development is a post-marketing surveillance trial. After a drug has been approved by regulatory authorities and made available for general use, Phase 4 studies are conducted to monitor the drug's performance in real-world settings. Key aspects of these studies include:

1. **Safety Monitoring:** Ongoing assessment of the drug's safety profile, especially long-term side effects that might not have been apparent in earlier phases.

2. **Efficacy in General Use:** Evaluation of the drug's effectiveness when used by a broader population outside of clinical trials.

3. **Comparisons and Combinations:** Testing the drug in combination with other therapies, or comparing it against other drugs available for the same condition.

4. **Identification of New Uses:** Investigating potential new indications or uses for the drug.

Phase 4 studies provide valuable data that can lead to the optimization of drug use, better understanding of side effects, and overall improvement in patient care.” —ChatGPT