PharmaTher Holdings Ltd. has applied with the U.S. Food and Drug Administration ("FDA") to receive Orphan Drug Designation ("ODD") for ketamine to treat Status Epilepticus ("SE"), a rare neurological disorder requiring emergency treatment for a seizure. The Company has received FDA ODD for ketamine to treat amyotrophic lateral sclerosis ("ALS") and complex regional pain syndrome ("CRPS"). The addition of SE strengthens the Company's pharmaceutical strategy in developing novel uses and delivery methods (i.e. microneedle patch) for ketamine to treat rare disorders and life-threatening conditions. SE is a life-threatening occurrence of a prolonged seizure or recurrent seizures without recovery of consciousness between seizures (Lowenstein 1999) lasting more than five minutes. Epidemiological studies found an annual incidence of SE ranging from 41/100,000-61/100,000 (DeLorenzo 1996). Based on these studies, there are approximately 120,000-180,000 episodes of convulsive SE each year in the U.S. SE affects individuals of all ages and it complicates various neurological and systemic illnesses. If SE is not treated immediately, permanent neuronal damage may occur, contributing to high morbidity and mortality rates. The mortality associated with SE is estimated at 17% and may lead to morbidity, including cognitive defects and neurological injury. SE is initially treated with benzodiazepines, which approximately 35-45% of patients are refractory to benzodiazepines.