OTLK - GROWTH STRATEGY WITHOUT THE FDA

In addition to sales in other European Union countries, when will sales begin in Canada?

Health Canada and the EMA offer a joint review pathway for marketing authorization applications, allowing pharmaceutical companies to submit applications simultaneously to both agencies.

When will marketing approval in Canada and sales begin?

Canada population 41.57 million

Middle East population 260 to 430 million (Distribution and Sales with MS Pharma)

Japan population 124 million

India population over 1.4 billion

Sales of ONS-5010/LYTENAVA™ (bevacizumab) in these countries, and also sales in all European Union countries, could be success factors for OTLK without FDA approval.