Drug Name: CBP-1008 for injection
Proposed indication: Platinum-resistant Ovarian Clear Cell Carcinoma (OCCC)
The following criteria are required before Coherent Biopharma would consider patients eligible for expanded access to a Coherent Biopharma investigational product. All criteria are subject to local laws and regulations.
• Marketing approval in at least one major market globally.
• The use of the investigational product in an expanded access protocol is compliant with local rules and regulations.
Coherent Biopharma cannot approve expanded access use requests in cases where doing so would violate company policy, local laws or regulations, or if access would present an unacceptable benefit/risk profile, as deemed by medical personnel of the company.
We commit to a careful and fair evaluation of each request by the appropriate medical experts at Coherent Biopharma within the boundaries of local laws and regulations. All requests for expanded access (typically made by the treating physician) will be acknowledged by medical personnel from Coherent Biopharma (or our agent) within 7 business days. Should the request be approved, the requestor must enter into an Expanded Access Agreement with Coherent Biopharma.