ClarificationiBlue is not some novel drug or revolutionary treatment option for cancer patients going through early drug clinical trials to see if it even works.
It is a hybrid cancer imaging technology which combines 2 existing and well established cancer surgical viewing methods to a superior imaging display ideally suited for surgical use not only in bladder cancer, but soon to be other cancers as well.
It utilizes existing FDA-approved fluorescence agents and non-invasive procedures to improve surgeons' ability to view and completely resect cancer. iBlue is by definition as effective for effective screening to prevent unnecessary surgeries as it is for actual cancer resections.
The top AUA urologists who have seen both the initial device and the recently re-designed modular device demonstrations at the last 2 conferences are "overwhelmingly positive" on iBlue. We have yet to hear of a single urological surgeon who disputes the dire need for iBlue. For 2 years IME has demonstrated the product to the surgeons who will be using it and they have seen it with their own eyes and confirmed it will be a "welcome advancement" to their field.
Bladder cancer recurrence rates are notoriously high (50%), due in large part to inferior surgical imaging tools. iBlue is a long-needed cancer imaging evolution that addresses this. It probably will be on the market as early as Q2 2020.
Fraudulently calling a clinical study a failure when it clearly was not is illegal. At worst it was inconclusive because apparently no cancer was detected in the 6 subjects. That is not a failure of iBlue, it is a failure of cancer to show up to the research study. You can't measure dwell time on viewing cancer which is not there. Doctors routinely send recovered cancer survivors for additional tests to make sure it has not returned.
Go re-read the July update, give your head a shake, and re-think your position. The notion that a technology company after 3 years of development and re-design for manufacturability, on-boarding top medical device specialists from Boston Scientific and the like, ongoing consultation with FDA and top urologists at Rochester U, and now going to pilot production is some kind of fraud, is simply absurd.
The next FDA meeting is in the next 1-2 weeks to decide iBlue's approval path. Expect clarification on the timeline and any final regulatory requirements. The FDA knows a 50% bladder cancer recurrence is insanely high and completely unacceptable.
There is government and medical community pressure to solve this expensive problem. Since there is virtually no downside or patient risk to approving iBlue, leading urologists are "overwhelmingly positive", and the FDA is very familiar with the IME team, expect a good meeting result.