MycoVa™ has successfully demonstrated 'non-inferiority' for the treatment of onychomycosis compared to the current standard of care in Europe for topical therapy, Loceryl^®. In the study, 1,029 patients with mild to moderate nail fungus were given either MycoVa™ (a topical 10% terbinafine hydrogen chloride formulation) or Loceryl^® (5% amorolfine nail lacquer) for 48 weeks of treatment. The primary objective endpoint was a complete cure. The secondary endpoints were killing the fungus and improving the appearance of the nail. The reanalysis of the results showed no significant difference in either the primary or secondary endpoints between MycoVa™ and Loceryl^®, which is a registered trademark of Galderma. Based on this data, we are preparing for pre-marketing authorization meetings to request guidance and actively exploring our options to file for marketing authorization in Canada, Europe, the Middle East and certain parts of Africa at this time.

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  Pre-NDA stage
  
  Partnered in Canada with Stellar Pharmaceuticals; Pre-NDS
  
  Partnered in certain Middle Eastern countries with Elis Pharmaceuticals
  
  Worldwide (ex-CAN, MENA) available for partnering
  
  Market estimated to be $500M (WW)