Osteal Therapeutics does not currently have a program offering expanded access to its investigational drugs under section 561(b) of the Federal Food, Drug, and Cosmetic Act. As such, Osteal Therapeutics has no established procedure for making such requests and no established criteria for evaluating such requests.
Patients or medical professionals seeking additional information may contact . All responses to requests for expanded access to investigational drugs will state that Osteal Therapeutics does not have an expanded access program at this time. Osteal Therapeutics commits to responding to requests within five (5) business days of receipt.
Individual patients seeking to access investigational drugs may be able to do so by participating in ongoing clinical trials. Whether or not a patient is eligible to enroll in any related clinical trials depends on a number of factors, including the specific requirements of each trial and enrollment status.
For more information about ongoing clinical trials of VT-X7, visit https://clinicaltrials.gov/ct2/show/NCT04662632.