Ann: SUDA Enters Agreement To Develop Cannabinoid Spray, page-91

What about the claim re - avoiding the need for costly effficacy

SUD-001 | Oral spray for migraine
§ SUD-001 is first oral spray of sumatriptan (GSK’s Imitrex® tablet) for rapid relief of migraine headache
§ Migraine market is approx $3.2 billion. Sumatriptan has 50% market share
§ Phase II study showed quicker onset of ac>on and less drug needed to achieve pain relief vs. Imitrex® tablet
§ Primary Market Research suggests prescribers & payers see important role for SUD-001 in pa>ents with nausea, GI problems or sudden onset headaches
§ Successful mee>ng with FDA in July 2015 regarding pivotal development plan - FDA accepted novel pharmacokinetic trial design, thus avoiding the need for costly efficacy studies prior to approval