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BNHLF (MC $33 M) BLA Filing for BIG

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BioSpecialist   Friday, 01/09/15 11:11:50 AM
Re: None
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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

Price: $0.19


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

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