BRC Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies for serious or life-threatening diseases. We are committed to developing safe and effective new treatments and obtaining regulatory approval as quickly as possible, so that our medicines can be made available to patients with unmet medical needs. We believe the most appropriate way to access our investigational medicines is through participation in our ongoing clinical trials.
In compliance with the 21st Century Cures Act (21 U.S.C. § 360bbb-0), this policy describes our approach to expanded access requests for our investigational drugs.
At this time, BRC Therapeutics is not offering an Expanded Access Program for any of its investigational products.
Our primary focus is on completing the ongoing clinical trials that are necessary to gather the safety and efficacy data required for potential marketing approval by the U.S. Food and Drug Administration (FDA) and other global regulatory agencies. Providing investigational drugs outside of a controlled clinical trial setting could interfere with, delay, or compromise the timely completion of these critical trials, which could delay the drug from becoming widely available to patients.
We may re-evaluate this policy in the future as more data become available or as our clinical development programs progress.
As we are not offering expanded access, we are unable to accept requests for individual patient expanded access at this time.
If a patient has a serious or life-threatening condition, we strongly encourage the patient and their treating physician to consider participation in one of our clinical trials. Information regarding our ongoing clinical trials can be found at www.clinicaltrials.gov.
Physicians and patients seeking information about BRC Therapeutics clinical trials or this policy may contact us at: info@brctherapeutics.com.
