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A couple of notes from the CC:

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H2R   Thursday, 11/08/18 12:10:24 PM
Re: None
Post # of 196 
A couple of notes from the CC:

On Finances:

"Importantly, as a result of our change in focus to prioritize Andexxa, we've been able to extend our cash runway into the first half of 2020."


On Andexxa adoption:

" We estimate that more than 4 million people in the United States are currently taking a Factor Xa inhibitor, and we expect that number to continue to grow at strong double-digit rates."

"We believe the success we are having in getting formulary approvals, orders and reorders is setting us up nicely for the anticipated launch of Gen 2 in early 2019."

"While our focus is on the Andexxa U.S. market, we continue to assess our European launch strategy as we approach the CHMP opinion date."

On PAS:

"we are on track for the December 31, 2018 PDUFA data for the anticipated approval of our Andexxa Gen 2 manufacturing process. In fact, we just received notification from the FDA that the PAS was deemed okay to file."

From the Q&A on targets:

" The tier 1 or our first set of targets are about 600 U.S. hospitals are Level I or Level II trauma centers or have Comprehensive Stroke designation. So those are the biggest institutions across the country. The next tier of about 900 additional accounts, additional hospitals were the Advanced Stroke Center designation."

Overall a very good CC in my opinion.

It will take time for the PPS to move, but it will move once revenue start pouring in.







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