Chuca,
I thought I had written a message a few hours ago, but it didn't get posted. I liked the the previous SI format much better.
Inflazyme received a letter from Cortecs a few days ago, but from my understanding it stated nothing conclusive. They were going to send Elisa (which is hospital-based) test kits to IZP. Then Inflazyme will conduct testing, under the aegis of a pulmonologist at Vancouver General Hospital. These will be part of the studies for what I assume to be the Canadian version of the FDA. I am inferring this as I was not told specifically. I was told that it was a research and marketing (through education?) study, but this left me confused.
I spoke with the project manager at Cortecs this morning, and I think he was somewhat annoyed. What I got out of this conversation was that approval from regulatory agencies in North America and Japan will take longer, but that in the UK, other countries in Europe, and other countries worldwide they do not require more review as Inflazyme had previously conducted studies. In fact, Cortecs can go commercial without further testing anytime it feels ready to do so in these countries as long as it meets quality assurance protocols. What they are doing now is testing the efficacy of the test in various locales to make sure that it picks up all or most all of the cases. In places where it does not do so, they may have a battery of tb antigen tests for different strains. But remember, IZP's test did the best job of worldwide screening for tb.
One thing I would like to clear up. I previously stated on this thread that Inflazyme's royalties for this test were 12%. I got this figure last year from James King, the Godfather of Investor relations. The figures are 10-12% for the Elisa tests and either 6-8 or 7-9% for the point-of-care tests, which will come out after the Elisa tests. The range of royalties in each case is affected by costs and quantities of tests sold.
I don't believe that Cortecs is far behind with the point-of-care tests because they have had ongoing discussions with the World Health Organization regarding reimbursement.
It may seem like there are delays in the testing, but that's mainly where the FDA and like agencies are involved. It's obvious that the Elisa tests could be marketed in some countries fairly soon, but that it will be when Cortecs has completed its studies of geographical strain specificity.
HL |
