Expanded Access and Compassionate Use


Expanded Access and Compassionate Use

At BERG we are driven by our passion to bring meaningful improvements to the lives of patients. To do this, BERG conducts clinical trials to evaluate the safety and efficacy of investigational medicines so that we may obtain the necessary approvals to provide these drugs to the populations in need.

Prior to such approval, participation in one of our clinical trials is the optimal way for patients to

gain access to our investigational medicines. However, we understand that some patients may

not be able to participate in a clinical trial and may seek access to investigational treatments

before they are approved.

In some extreme circumstances, patients with serious diseases may seek access to investigational therapy outside of a clinical trial setting. These situations are typically referred to as expanded access or compassionate use.

There are strict regulations for patients to be eligible for expanded access, for which your physician can apply. In close cooperation with your physician, BERG, under special circumstances, is willing to evaluate patient requests for expanded access to its clinical product candidates in the United States.

These circumstances are as follows:

  • The patient’s disease is serious or life-threatening.
  • There are no alternative therapies or clinical trials available for this disease.
  • There is data to support the safety and the efficacy of the product in question.
  • The risk/benefit to the patient is acceptable.
  • There is no indication that this provision will hinder further development of the investigational drug.
  • There is adequate drug supply available.

The administration of the drug will be overseen by an experienced physician licensed in the United States who is able to administer the drug per instruction and monitor the patient’s status while on drug.

At any point, expanded access or compassionate use can cease at the discretion of Berg. This policy may change without notice.

For further information on available clinical trials and expanded access programs, visit www.clinicaltrials.gov and search for trials where BERG is the sponsor.