SUD 0.00% 4.2¢ suda pharmaceuticals ltd

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

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    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
 
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