How many trials, and how long will it take, until FDA approved and then in place.
It obviously can not go thru a double blind study, diabetics need the real thing, not a placebo, or they die.
So what type of trial will it go thru for effectiveness study, and how long will it take ??
Will this really take the place of the glucose meters today that are cheaper to use ??
What advantages does this system offer ?? My friends little girl has juvy diabetes, and she sticks her self and then her parents give her the needle. Soon, by the age of ten, she will know how to do it herself, in case of an emergency.
They haven't announced either the EU ore the US trial designs yet. One trial for each, as far as I know. They thought the EU trial would be 50 patients or fewer. The US trial will be larger, but the data from the EU trial will be used to support the US trial. We need an update from the company. I think their timetables from last year are slipping.
True, they can't do a blinded study. There are easy ways to verify the readings, so I don't think it's a big deal. The company has already run 10 non-FDA trials. Whatever the protocol was in those trials I am guessing was designed to duplicate what will be used in their EU and US trials. I hope we get news of the EU trial very soon.
This meter will not replace the home meters that individuals use today. It's designed for institutional use. But the company should be able to adopt the design for home use once they have FDA approval. If I had to start putting dates on all this - EU approval the end of this year, EU sales start in 2014. US trial starts in 2014, sales in 2015. Home use in 2016. The company should have updates shortly.
I'm tired of being blindsided by their secondary offerings after being told they have enough cash to get to EU approval. It's happened twice. I am hoping they get a partner soon so they won't have to do that any more. But because of that, any price spike from a positive PR - but that doesn't include news of a partner - I'll sell into that rally.
This is a medical "device" not a drug. The research studies by nature are far less stringent. Most of that work has already been done. Feasibility studies are complete. I would expect EU approval would occur between now and June. The roll out will be for critical care patients first. The Home users are a definite target market. Costs will mitigate as we progress. The home market is where the "pot of gold" lies. For me to know what my blood sugar is at any given time is invaluable, even as a Type2 patient.
That being said, I don't think any of us will see the real benefit from the technology. I think they will be bought by a larger entity before it becomes too expensive to do so. I am hoping we get back to the $2 to $3 range before we get shopped around.
I DO heartily agree that I hate the way they did their financing. After Mooney said DIRECTLY that they had no plans for a secondary, then dump the stock on the market for 60% of it's value...? I am sure that there is a side story to that also.
This thing has potential in the Billions, sadly we original investors will not see the bulk of it.
That is where the "level playing field" is not so level for all of us.