LAM-002A will be provided for expanded access for an individual patient under 21 CFR 312.310. It will be administered BID orally at a dose of 125 mg. Assessment of safety will include clinical observations and monitoring following administration.
This is an open-label, single subject, expanded access protocol (EAP) of the LAM-002A investigational product administered orally at 125 mg BID for 52 weeks.