About 5/6 Years, How We doin?Opportunity
Complete a FDA Phase 1/2a human bladder cancer clinical study with FDA breakthrough status.
Execution of a strategic partnering agreement with big pharma for destruction of bladder cancer
(i.e.: upfront payments , co-development funds, annual recurring revenue streams)
Strategy
2013 - Milestone 2 (complete): Destruction of cancer in a live animal mouse model. Demonstrated >99% efficacy for a subcutaneous cancerous tumour.
2014 - Milestone 3 (in progress): Complete validation in orthotopic rat model, dose toxicity study, GMP drug manufacture and FDA Investigational New Drug (IND) application.
2015 - Milestone 4: Complete FDA phase 1/2a human clinical study with FDA breakthrough status
2016 - Milestone 5: Execute strategic partnering agreement with big pharma
Risks:
Scientific Risk. in-vitro and small animal in-vivo results show virtually zero toxicity and up to 100% cancer kill across a wide range of cancers.
Manufacturing Risk. Drug manufacturing will be outsourced to a GMP facility. Laser design will be completed by Theralase which is iso-13485 certified and has designed and manufactured laser sydtem,s for over 20years. Manufacturing of sub com,ponents will occur at iso-9001 manufacturing facilities.
Regulatory Risk. Very low as anti-cancer technology has demonstrated up to 100% effectiveness in bladder cancer cells with virtually zero toxicity as it never enters the blood stream. FDA is very supportive of approving new cancer drugs.
Financing Risk. $3.15M financing completed in November 2013 to commercialize next generation therapeutic laser and commence phase 1/2a anti-cancer clinical trial.
Liquidity Risk. Company currently trades on the TSXV under ticker TLT and is a fully reporting issuer.
Execution Risk. Outsourced to Princess M<argaret Cancer Centerm, one of the top 5 cancer institutes in the world. Canada's top uro-oncologist and Head of Urology at Princess Margaret Cancer Centre will lead bladder cancer clinical trials.