Theralase Technologies

Quick timeline from my notes that we can complile/add to here if anyone has feedback. It was a good year,,, delays on TLC2000 but progress on pdc gmp and cro side as well as exciting invivo rat data. 2015 should be a fun year to study TLT news, progress/results and see where this might take us. This is forward looking. Study the science, the relevant markets, the team and company, make your own decisions whether it is worth grabbing a speculative position early or whether you need to see things unfold this year. Do your own DD!!

Approximate/Rough timeline:

• 4Q2014 TLT - Transition from TLC1000 to not yet released TLC2000 will likely see light 4Q2014 sales numbers as customers wait for new product
• 1Q2015 TLT - TLC2000 - Approvals - Hoping to see Regulatory approvals first quarter
• 1Q2015/2Q2015 TLT - TLC2000 - Launch - "Theralase will launch the patented, next generation TLC-2000 biofeedback therapeutic laser system in Canada in 1Q2015 and in the US in 2Q2015."
• 1Q2015 PDC - Optimization of the dose of laser light and PDC required in its orthotopic rat model to further refine this procedure for the destruction of bladder cancer in a live animal model.
• 1Q2015 PDC - Conduct Health Canada Clinical Trial Application ("CTA") / Food and Drug Administration ("FDA") Investigational New Drug ("IND") meetings
• 2Q2015 PDC - Complete pre-Good Manufacturing Practices ("GMP") and GMP manufacture of lead drug
• 2Q2015 PDC - Identification of toxicity laboratory and completion of toxicity analysis of the lead compound in 2 different animal species
• 2Q2015/3Q2015 TLT - Waiting to see TLC2000 sales data/traction
• 2Q2015/3Q2015 PDC - Health Canada and FDA CTA / IND Regulatory Approval for PDC treatment
• 3Q2015 PDC - Commence enrolling subjects into Health Canada / FDA Phase I / II a bladder cancer clinical study for NMIBC (Pending Regulatory Approval)
• 3Q2015 TLT - TLC2000 international sales targetted
• 3Q2015/4Q2015 - PDC - Trials commence - Treatments started
• 4Q2015 PDC - Twelve week followups starting in this period
• 1Q2016 - PDC- Final data compiled/ complete phase 1/2a bladder clinical trial - results submitted to FDA
• 2016 Waiting for FDA approval/feedback for fasttrack/commercialization
• New Drug Application (NDA)

Theralase believes they have a 99% chance of achieving Fast Track Status and after completion of a successful Phase 1/2a clinical trial over a 90% chance of achieving Breakthrough Status.

2016
(DOES Phase 1/2a trial demonstrate safety and efficacy and does treatment qaulify for Fasttrack??? YES=commercialization NO=Phase 2b)
YES = PDC approval-Commercialize PDC!
NO = FDA needs more data - 2016 - Commence Phase 2b (15M approx. cost if needed)

------------------
Fasttrack?

Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:

-Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
-Avoiding serious side effects of an available therapy
-Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
-Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
-Ability to address emerging or anticipated public health need

A drug that receives Fast Track designation is eligible for some or all of the following:

-More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
-More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
-Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
-Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

-----------------

If Phase 1/2a goes according to plan and Fasttrack is requested and granted, we're pretty much moving forward with a new future and new timelines for commercialization and starting the next Cancer model. TLT has stated, that once bladder cancer treatment is approved they want to start their next cancer in 2016. They also have the bacteria PDC's that could open new doors and TLC3000 commercialization. If additional Phases for bladder were needed, that instead would be the focus of 2016 an on.

----------------