Bioatla, Inc

Expanded Access is a potential pathway for patients diagnosed with a serious and/or life-threatening disease or condition to gain access to an investigational product for treatment outside of a clinical trial when no comparable or satisfactory alternative therapy options are available. In these instances, a patient’s treating physician can request an investigational product prior to regulatory approval, where allowed by local laws.

Who is Eligible for Expanded Access Programs?
BioAtla considers granting expanded access to its investigational products when all of the following criteria are met:
• A patient is diagnosed with a serious and/or life-threatening disease or condition.
• There are no adequate standard or investigational therapies available.
• The patient is not eligible for or cannot participate in a BioAtla-sponsored study for the therapy being requested.
• There must be adequate data supporting use of the investigational medication in the treatment of the patient’s
disease.
• Adequate supply exists to support both the ongoing clinical trials and expanded access, until and if a product
becomes commercially available.
• Expanded access will not adversely impact the clinical development program or the regulatory approval process.
• The request must be made, unsolicited, by the patient’s treating physician.
• The treating physician must also agree to comply with the safety and monitoring requirements.
• Where appropriate demonstration of efficacy and safety may be required for continued treatment.
• Expanded access is permitted or approved in the country, region, and/or state where the investigational medicine
will be administered.
• Any condition, in addition to those listed above, that in the opinion of BioAtla may preclude appropriate use of the
investigational medicine, will be considered.