Hi que, many thanks, very helpful info:
Most remarkable to me is:
"The CDC plans to recommend that, pending revision of state and local laws requiring written informed consent -- a process that could take years -- HIV testing be offered to everyone ages 13 to 64. The test would be bundled with routine screening tests such as those for cholesterol and blood glucose as a normal part of care in doctors' offices, clinics, hospitals and emergency rooms."
So how is OTC sales and signing "informed-consent documents" before testing fitting to each other. It seems that getting OTC testing cleared by FDA is only one aspect of starting OTC sales. This sounds like a lot more laws have to changed as well which could require even more time. Is this correct here or have I missed something ?
"While the CDC stops short of recommending any specific test product, routine tests are enabled by the advent of rapid, inexpensive HIV tests such as OraSure Technologies Inc.'s OraQuick rapid HIV antibody test, which takes 20 minutes to determine if a person is infected with HIV. The test price ranges from $11 to $17 depending on the quantity ordered."
I don't get how $11 at minimum can be named inexpensive. Seems like OSUR was ghostwriting this article one more time again.
Based on this article I would say that US OTC is a long-term thing which is especially bad for OSUR which has a very important near-term focus on this and is in danger of creating currently false expectations. It is not too bad for Calypte because they get extra time to work on FDA and other basic approval things in the meantime and can reduce its "US regulatory handicap" in this way before things really heat up.
Calypte must be very focused to China and Africa in the short-term anyway (they cannot hit all markets at the same time realistically - my personal opinion) because they would have problems to pursue every opportunity at the same time.
The big cows (markets) to milk within the next one or two years are China/Africa markets and not US OTC. So Calypte's focus looks quite ok for the moment.
Some quick thoughts
Cal
AI
