Sponsor Overview
Explore verified public information about ECM Therapeutics, Inc.'s expanded access programs, compassionate use policies, and patient eligibility pathways. This report aggregates official statements, independent research, and regulatory data to help patients, providers, and sponsors collaborate efficiently.
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Expanded Access Intelligence
Official Statements
Score contribution: 100 — 1 supporting sources.
“ECM Therapeutics may consider providing such access through our Compassionate Use (Expanded Access) Program in accordance with applicable laws and regulations.”
Reagan-Udall Foundation Insights
Single-Patient EA Policies/Criteria ECMT has established a Compassionate Use Program (CUP) also referred to as Expanded Use under the regulatory and legal framework provided by the United States Food and Drug Administration (FDA) and current Right to Try laws. This program is designed for Single-Patient Expanded Access. If you are a physician or a patient, you may contact us to determine whether the ECMT CUP is appropriate. This program may include any of our ECMT investigational products that have been manufactured under Good Manufacturing Practice (GMP) conditions and rigorous quality standards. While we cannot guarantee these investigational products will be safe and efficacious for a particular patient who may be treated in the CUP, the company has established a Compendium of Evidence and Supporting Literature that physicians and patients are encouraged to review for their individual situation. The literature suggests similar ECM products have been used safely for over two decades for a large variety of clinical indications.
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