BNHLF (MC $33 M) BLA Filing for BIG Bladder Cancer vaccine in this Quarter .
Runup to FDA decision and Approval could drive this Stock close or over $2 per Share ! GL
Market Cap: $33 Million
Cash: $10 Million
Presention fron last month http://www.bioniche.com/pdf/2014/CEO%20Presentation%202014%20Annual%20General%20Meeting.pdf
Bioniche will file BLA with the US FDA, seeking approval for the commercialization of MCNA based on existing clinical data; Target filing date: Q1/2015 . Near term revenue opportunity in the U.S
Potential for marketing approval as early as end of 2015/early 2016 .Exploring potential for US listing .
Pivotal phase 3 study (completed) shows it can delay (or prevent) need for cystectomy (bladder removal) in 25% of patients with high-risk non-muscle invasive bladder cancer (NMIBC) who failed first line BCG treatment
Supported by strong intellectual property coverage
•Patent term expiration: 2031
•Automatic 12 year market exclusivity for novel biologic in US
Of all cancers, bladder cancer has the greatest lifetime treatment cost per patient diagnosed (US, 2010)
$230,000 . 80,000 new cases/year in North America .
Potential for peak U.S. sales of $200M plus .Comparable or greater market opportunity ex-US
•NMIBC BCG-failure population only
•50% market penetration
•$3,000 per dose