Monday, August 31, 2015 7:26:16 AM
Q: Will there be a compassionate use program?
A: Our primary focus at this time is working closely with NIH, FDA, EMA, leading NPC physicians and other experts to determine final study design. Once we complete enrollment in the clinical trial, we will provide more information related to access outside of the trial.
Pivotal VTS-270 Clinical Trial
We are designing a rigorous clinical study through which we hope to demonstrate a measurable positive effect of the drug. As the trial progresses, we will continue to assess its risk/benefit profile.
Although the trial design is not finalized and locations are still under consideration, Vtesse plans to have multiple sites in the U.S. and Europe and will be working with patient groups to better understand the needs of study participants.
We plan to continue to communicate regularly with the NPC community, parents, healthcare providers and others, and to provide regular updates and information about the progress of our trial. Our Clinical Trials (link) page will have an enrollment form and other clinical study information when available.
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