"The FDA's notification cites that the performance data provided in the submission did not demonstrate the device to be as effective as legally marketed devices. The Company notes that at present there is no legally marketed point of care saliva device."
How can the FDA compare it to a legally marketed device when there isn't one to compare it to. Obviously there has been some miscommunication between SBN and the FDA or we would have FDA approval now. We should know more about that in the coming weeks.
I also have dealings with Govt agencies in QLD and I can't say that the reaction time is immediate - not even close. Must be the weather up here.
I thought I was lucky getting in at 4.5c and am now trying to sell down my other stocks so I can buy more around 2c.
There is potentially a huge upside to this stock with China/Asia alone. FDA approval would have had an instant positive affect on the SP, that's a given. It's just going to take a little longer now.
Depends on how long you're prepared to hold for. I'm in it for the long hall and can afford to sit on a loss while things get back on track.
If you can afford to sit and wait it out, then you should do it. I'm reasonably confident that you won't be dissappointed at the end of the day. Good luck to you and all holders.
jd
SBN Price at posting:
0.0¢ Sentiment: Buy Disclosure: Held
