Edgewise Provides Statement Regarding Company’s Relationship with Dr. Han Phan at Rare Disease Research
Edgewise Therapeutics (Nasdaq: EWTX) has issued a statement clarifying its relationship with Dr. Han Phan at Rare Disease Research following an FDA warning letter. The company emphasized that the FDA's warning letter to Dr. Phan, issued on November 27, 2024, was based on her work with another company and is completely unrelated to any Edgewise clinical trials or data.
The company has conducted multiple audits of Dr. Phan's site and confirms that data from Edgewise clinical trials are being collected and stored in compliance with FDA requirements.
Edgewise Therapeutics (Nasdaq: EWTX) ha rilasciato una dichiarazione per chiarire la sua relazione con il Dr. Han Phan presso Rare Disease Research, in seguito a una lettera di avviso della FDA. L'azienda ha sottolineato che la lettera di avviso della FDA al Dr. Phan, emessa il 27 novembre 2024, si basava sul suo lavoro con un'altra azienda ed è completamente scollegata da qualsiasi trial clinico o dato di Edgewise.
L'azienda ha condotto più audit riguardanti il sito del Dr. Phan e conferma che i dati provenienti dai trial clinici di Edgewise vengono raccolti e archiviati in conformità con i requisiti della FDA.
Edgewise Therapeutics (Nasdaq: EWTX) ha emitido un comunicado para aclarar su relación con el Dr. Han Phan en Rare Disease Research, tras una carta de advertencia de la FDA. La compañía enfatizó que la carta de advertencia de la FDA al Dr. Phan, emitida el 27 de noviembre de 2024, se basó en su trabajo con otra compañía y es completamente ajena a cualquier prueba clínica o dato de Edgewise.
La empresa ha realizado múltiples auditorías del sitio del Dr. Phan y confirma que los datos de las pruebas clínicas de Edgewise se están recolectando y almacenando de acuerdo con los requisitos de la FDA.
엣지와이즈 치료법 (Nasdaq: EWTX)는 FDA 경고 서한과 관련하여 Rare Disease Research의 한 박사와의 관계를 명확히 하기 위한 성명을 발표했습니다. 회사는 2024년 11월 27일에 한 박사에게 발송된 FDA의 경고 서한이 그녀가 다른 회사와 함께 수행한 작업을 기반으로 하며 엣지와이즈의 임상 시험이나 데이터와는 전혀 관련이 없음을 강조했습니다.
회사는 한 박사의 사이트에 대해 여러 차례 감사했으며, 엣지와이즈 임상 시험에서 수집된 데이터가 FDA 요구 사항을 준수하여 수집되고 저장되고 있음을 확인합니다.
Edgewise Therapeutics (Nasdaq: EWTX) a publié une déclaration pour clarifier sa relation avec le Dr Han Phan au sein de Rare Disease Research suite à une lettre d'avertissement de la FDA. La société a souligné que la lettre d'avertissement de la FDA adressée au Dr Phan, émise le 27 novembre 2024, était basée sur son travail avec une autre entreprise et n'avait absolument rien à voir avec les
L'entreprise a mené plusieurs audits du site du Dr Phan et confirme que les données des essais cliniques d'Edgewise sont collectées et stockées conformément aux exigences de la FDA.
Edgewise Therapeutics (Nasdaq: EWTX) hat eine Erklärung abgegeben, um die Beziehung zu Dr. Han Phan bei Rare Disease Research im Anschluss an einen Warnbrief der FDA zu klären. Das Unternehmen betonte, dass der Warnbrief der FDA an Dr. Phan, der am 27. November 2024 ausgestellt wurde, auf ihrer Arbeit mit einem anderen Unternehmen basiert und vollständig unabhängig von Edgewise klinischen Studien oder Daten ist.
Das Unternehmen hat mehrere Prüfungen des Standorts von Dr. Phan durchgeführt und bestätigt, dass die Daten aus den Edgewise klinischen Studien in Übereinstimmung mit den Anforderungen der FDA gesammelt und gespeichert werden.
- Company confirms compliance with FDA requirements for clinical trial data collection and storage
- Multiple successful site audits conducted at Dr. Phan's facility
- Association with a clinical investigator who received an FDA warning letter may raise concerns among stakeholders
Insights
The FDA warning letter to Dr. Han Phan, while concerning from a general clinical research perspective, has no direct impact on Edgewise Therapeutics' clinical trials or data integrity. Several key points support this assessment: First, the warning letter specifically relates to Dr. Phan's work with another company, not Edgewise. Second, Edgewise has conducted multiple site audits, demonstrating proper due diligence in maintaining data quality and regulatory compliance. Third, their clinical trial data collection and storage methods appear to meet FDA requirements based on these audits.
This proactive disclosure by Edgewise serves to maintain transparency with stakeholders and mitigate potential market concerns. The company's swift response and clear delineation between their trials and the FDA warning demonstrates strong corporate governance and regulatory awareness.
On November 27, 2024, the
Edgewise has audited Dr. Phan’s site multiple times and believes that the data related to the Edgewise clinical trials at the site are being acquired and stored in accordance with FDA requirements.
About Edgewise Therapeutics
Edgewise Therapeutics is a leading muscle disease biopharmaceutical company developing novel therapeutics for muscular dystrophies and serious cardiac conditions. The Company’s deep expertise in muscle physiology is driving a new generation of novel therapeutics. Sevasemten is an orally administered skeletal myosin inhibitor in late-stage clinical trials in Becker and Duchenne muscular dystrophies. EDG-7500 is a novel cardiac sarcomere modulator for the treatment of hypertrophic cardiomyopathy and other diseases of diastolic dysfunction, currently in Phase 2 clinical development. The entire team at Edgewise is dedicated to our mission: changing the lives of patients and families affected by serious muscle diseases. To learn more, go to: www.edgewisetx.com or follow us on LinkedIn, X, Facebook and Instagram.
Cautionary Note
Edgewise’s statements are based only on limited and preliminary information and analysis. Additional information or further analysis may arise that could lead to different conclusions regarding Edgewise’s compliance with FDA requirements.
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding Edgewise’s compliance with FDA requirements and the impact of the FDA’s warning letter on Edgewise. Words such as “believe” and “expects” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon Edgewise’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the FDA being more likely to audit Edgewise’s clinical activities as a result of the FDA’s actions related to Dr. Han Phan; risks related to the regulatory approval processes being lengthier and more challenging as a result of the FDA’s actions related to Dr. Han Phan; risks associated with the operations of Edgewise’s clinical sites and Edgewise’s advancement of its clinical trials as a result of the FDA’s actions related to Dr. Han Phan; and risks associated with delays or difficulties in the enrollment and/or maintenance of patients in clinical trials as a result of the FDA’s actions related to Dr. Han Phan.
Information regarding the foregoing and additional risks may be found in the section titled “Risk Factors” in documents that Edgewise files from time to time with the
View source version on businesswire.com: https://www.businesswire.com/news/home/20241205281873/en/
Edgewise Contacts
Investors:
Behrad Derakhshan, Ph.D., Chief Business Officer
ir@edgewisetx.com
Media:
Maureen Franco, VP Corporate Communications
media@edgewisetx.com
Source: Edgewise Therapeutics
FAQ
What is the FDA warning letter to Dr. Han Phan about and does it affect Edgewise Therapeutics (EWTX)?
How has Edgewise Therapeutics (EWTX) ensured data quality at Dr. Phan's research site?
When did the FDA issue the warning letter to Dr. Han Phan affecting Edgewise Therapeutics (EWTX)?
