Edgewise Therapeutics Provides Statement on Relationship with Dr. Han Phan

Background

On November 27, 2024, the U.S. Food and Drug Administration (FDA) issued a warning letter to Dr. Han Phan at Rare Disease Research following a site inspection related to her work with another company. This warning letter is not connected to any clinical trials or data from Edgewise Therapeutics.

Company’s Response

Edgewise Therapeutics, a leading muscle disease biopharmaceutical company, has provided information regarding its relationship with Dr. Phan and clarified that the warning letter issued to her does not impact any of their ongoing research or trials.

Impact on Individuals

For individuals participating in clinical trials or seeking treatment for muscle diseases, it is important to note that Edgewise Therapeutics’ operations remain unaffected by the warning letter issued to Dr. Han Phan.

Global Implications

While the warning letter to Dr. Phan may have raised concerns within the medical community, it is crucial to understand that this issue is specific to her work with another company and does not reflect on the integrity of research conducted by Edgewise Therapeutics.

Conclusion

It is essential for stakeholders to stay informed about the latest developments in the pharmaceutical industry and to discern between isolated incidents like the warning letter to Dr. Phan and the broader work being done by companies like Edgewise Therapeutics to advance treatments for muscle diseases.