General Chat, page-19

The typical clinical trials timeline looks something like this, note this is generally for medicine but it applies to medical devices and processes too. This is the standard rollout for US based studies which is relevant knowing IBX's roots, base and future predominant focus is in the US.

Phase 1: These trials usually enroll 20 to 100 volunteers with the condition being studied, and last several months. This phase measures safety by testing for any adverse side effects of the treatment, method or device, but not necessarily how effective the drug or device is.
IBX note: starting this month, high chance of success for safety given animal testing.

Phase 2: Around 70% of potential new drugs / treatments enter Phase 2, which continues to measure safety, while also looking at how effective the treatment is and carefully investigating its side effects. Phase 2 trials recruit up to several hundred patients with the condition to take part. This phase typically lasts several months to two years.
IBX note: no drugs involved so no side effects or need for prolonged testing. I would say the 'several months' applies over the 'two years'.

Phase 3: Just 33% of studies make it to Phase 3, which tests the potential treatment in the largest number of people. This phase measures both safety and effectiveness with many volunteers, sometimes thousands. Phase 3 trials last from one to four years.
IBX note: As per note in Phase 2.

FDA approval: After Phase 3, a pharmaceutical company may submit a New Drug Application (NDA) or a biologics license application (BLA) for the treatment to the Food and Drug Administration (FDA). The FDA then reviews results from all stages of the trial to determine whether it will approve the drug and allow the pharmaceutical company to begin marketing it to the public.
IBX note: IBX already an FDA Breakthrough Device designation, which means a serious fast track to FDA approval, compressing the timeline in IBX's favour.

Phase 4: This phase is often called “Post-Approval Research and Monitoring.” After a new treatment is approved by the FDA, the pharmaceutical or device company may want to continue monitoring patients to learn more about the treatment’s longer-term effects, while comparing it against other already-approved options. It may take time for long-term side effects to appear, making this an important phase.

The major advantages IBX has within this context are:
- Phase 1 a very high probability of success (and major re-rate + publicity) due to low risk of any adverse effects
- Various intravenous nanoparticle injection studies have alreadey been proven safe
- no medicine involved, non intrusive process - will shorten the amount of time each phase takes as side effects, long term impacts etc are reduced to a much smaller set of metrics
- FDA Breakthrough Device designation - will allow for a much faster FDA approval and an 'express lane' for communication with the FDA

In summary
IBX 'full results' won't be knows in months but rather in years. I would say 2-3 years to commercialisation approx assuming no major hiccups. However, an indication of progress will be provided along the way and not only at the points of the big milestones (end of each phase). Knowing what we know, there is a huge chance of phase 1 being successful, which will create a lot of excitement and publicity around the company. The rest of the process will take longer and potentially not be as exciting a journey along the way but this is not to say that other news (eg. partnerships, deals, etc) will not eventuate during this time to add some colour to the story.

So if you are bullish, it's a long term game and a long road to commercialisation. There will be periods of letdowns, inactivity, turbuence of many sorts and the road to the end goal will be long, hilly, rugged and winding. So it won't be an easy hold (the hardest thing in investing is to hold) and it may also end up a complete flop. However if trials are successful and the solution commercialised in 2-3 very short years, this company can prove life changing for many (deca $B mcap+, dividends, on going growth, juicy takeover, etc).