Vanda Pharmaceuticals FDA Update for HETLIOZ® in the Treatment of Jet Lag Disorder
In the CRL, the FDA asserted that these measures demonstrating improved sleep are of unclear clinical significance.
- In the CRL, the FDA asserted that these measures demonstrating improved sleep are of unclear clinical significance.
- Vanda intends to consider each observation as it plans for continued engagement with the FDA on this matter.
- "Vanda remains committed to obtaining FDA marketing approval for tasimelteon in Jet Lag Disorder in order to address this significant unmet medical need."
- Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf.