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Monday, 09/15/2014 9:33:04 AM

Monday, September 15, 2014 9:33:04 AM

Post# of 60
BNC.TO (MC $40 M) BLA Filing in 1Q for Bladder Cancer vaccine

The Drug is effective and has great safety Profile and im sure it will work even on other types of cancer because Bladder Cancer is one of the hard to treat .. MarketCap of around $40 M (includes the current Share Offering) is very very cheap for a Biotech who has a big cancer Drug that completes all clinical studies successfully .

I think a price target of $2 within 12-18 months is realistic ....


Bioniche Life Science (BNC.TO) << Canadian Stock

Market Cap $40 M
Cash $15 M
Price $0.21



Bioniche Announces Q1/2015 Timeline for the Filing of a Biologics License Application for Marketing Approval of MCNA in the United States..
http://finance.yahoo.com/news/bioniche-announces-q1-2015-timeline-120000914.html



Latest Presentation
http://www.bioniche.com/pdf/2014/Bioniche%20Non-Conifidential%20Presentation%20June%202014.pdf



MCNA Phase 3 Study-Summary

Bioniche completed an open-label, single-arm Phase 3 trial with MCNA suspension.
Objective was to evaluate the efficacy and safety of MCNA in patients with
NMIBC at high risk of recurrence and progression who had failed BCG therapy
Total of 129 patients with high grade papillary and/or carcinoma insitu (CIS) who had failed (refractory or relapse) to respond to one or more courses of BCG were enrolled across 25 centers in U.S. and Canada
.

MCNA-Phase 3 Overview Strong Potential as Salvage Therapy
25% overall DFS rate at 1 year
35% DFS rate in patients with papillary tumors only at 1 year

Response to MCNA treatment provides several additional clinical benefits
•Based on post-study analyses benefits included:
•Long duration of response
•Reduced rate of cystectomies
•Reduced risk of progression

Excellent safety and tolerability profile
Most adverse events reported were mild to moderate in severity.
No special handling or disposal required



Market Potential

The Company has conducted an internal assessment of the potential available patients in the U.S. on a yearly basis, using a watershed/stratification of published NMIBC epidemiology data and guidance from urologists experienced in the treatment of the disease. Based on internal analyses, the Company projects that there are approximately 8,500 new available patients in the U.S. each year. Based on these patient number assumptions, and making certain estimates of drug pricing, unit volume and market penetration rates, the Company estimates that in the U.S. the market potential for MCNA in BCG-failures could approach $200 million per year. The Company is in the process of engaging an external firm with expertise in market research, commercial assessment and market access (pricing and reimbursement) in order to validate these internal estimates and obtain sales forecasts based on various commercial scenarios.
Read more at http://www.stockhouse.com/companies/bullboard/t.bnc/bioniche-life-sciences-inc#gExUb8gpcy8sdFJm.99