Expanded Access
Vima Therapeutics, Inc. (Vima) is focused on developing safe and effective treatments for patients with movement disorders. The development process for investigational medications (e.g., possible treatments) requires extensive evaluation of their safety and efficacy through clinical studies. We are working closely with scientists, physicians, clinical study sites, advocacy groups, patients and their families to conduct our clinical studies. When completed, data from these studies will be provided to regulators (i.e., FDA, EMA, or similar regulatory agencies) for review and potential approval. Approved Vima products will be made available through normal commercial channels.
We understand that patients and their families may be interested in accessing our investigational medications outside of the clinical study setting and prior to regulatory approval through an expanded access program (a.k.a. “early access” or “compassionate use”). Vima does not currently offer access to its investigational medications through an expanded access program. At this time, a clinical study is the only way to access potential medications currently under development at Vima. Vima’s decision not to provide expanded access at this time reflects its evaluation of the stage of development of its investigational medications inclusive of the breadth of safety and efficacy data available for these investigational products.
Vima will reassess this position as its development programs progress and reserves the right to revise this policy at any time. The posting of this policy does not guarantee access to any investigational medication. Requests for additional information about our policy may be directed to expandedaccess@vimatx.com.