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LabStyle Innovations Corp. Message Board

  • rrtzrealmd rrtzrealmd Jul 23, 2014 9:16 PM Flag

    What happened to the 510K?

    ...DRIO subitted the application back in December, didn't they? ... the FDA says they try to get out some sort of reply within 90 days but a more realistic time frame for approval is 6 months -- last year the average was 166 days...well, here we are almost into 8 months now and still no word?...

    ..what's especially worrisome is that ihealth submitted the 510 application for their world's smallest glucometer with strips that cost SEVENTY FIVE per cent LESS than other glucometers in December as well...and guess what!...they got THEIR approval on May 22, 2014...that was TWO MONTHS ago!...

    ...given that the ihealth device looks a lot like the dario but is obviously VASTLY SUPERIOR, as well as the fact that it's backed by Andon Health, Ltd -- "the world's leading home health product manufacturer" -- might cause shareholders to wonder whether they're being left behind in the dirt...

    ...wouldn't it be nice for DRIO to assuage their fear by explaining the delay?...

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    • ...oh, my!...look!...a BAGHOLDER party!!...I just love these!...gnarling and gnashing of teeth as their precious hits YET ANOTHER ALL TIME LOW!!!...HAW!!...what;s the matter, bunky, the patent angle wasn' working out for you?...HAW!!!...

      ...I love that "apparently exceeding...expectations" -- but "apparently" not TOO apparent since the stock is DOWN yet ANOTHER 10% today!...HAW!!!...

      ..."why do you think analysts are issuing share price targets from $6 (Aegis) to $12 (Goldman-Sachs)"...hmmmmmm...let me think...let...me...think...oh, wait!...how about because they got a truckload of inventory that they want to sell to SUCKERS like YOU!...HAW!!!...

      ..."Be patient"???...why, of course!...why not?...wait until 2015?...sure!...all the while ihealth -- backed by a major firm -- penetrates the market further and further and...well, you get the picture!...

      ...of course, by then, what with all the FREE stock and warrants DRIO will have to distribute with each "readjustment period" -- more appropriately called "shareholder a_srape period" -- as its stock drops lower, no doubt there will be truckloads of shares waiting for purchase!...

      ...and batteries?...well, figure what with the SEVENTY FIVE PER CENT patients will be saving on the cost of strips, I somehow doubt that they will be worried about batteries...say, how much was DRIO expecting to earn off the sales of its strips?...HAW!...maybe they'll be able to make up the difference from sales of the special lancets required for dario, huh?...HAW!!!...

      ...funny, isn't it, how DRIO management hasn't said word one even as the stock continues to PLUMMET?...

    • You're the only one who thinks the ihealth device "is obviously VASTLY SUPERIOR". The device requires bluetooth and is considered a pain in the butt by many who have tried it. Even a cursory glance of diabetes and medical websites and blogs presents overwhelming evidence of the excitement by actual users about the Dario device. Several blogs are featuring it as the best glucometer device now available. The European launch is apparently exceeding the already high expectations, if reports are to be believed. Goldman-Sachs recently gave DRIO a $12 price target, based on conservative estimates. The BS you've been obsessively posting all over the place is nothing if not inventive: so now there is supposedly a problem with the FDA application? You don't have a clue what you are talking about (although you proved on Seeking Alpha that you also don't really care) with reference to the FDA application. The expected formal response schedule of late 2014 or early 2015 is entirely normal. There's nothing "especially worrying"; why do you think analysts are issuing share price targets from $6 (Aegis) to $12 (Goldman-Sachs) after the FDA application? Why do you think the roll-out across Europe and now in Canada is so successful? Hey, "Bearcrusher" and whatever other tags you use, keep trying.

    • Hasn't even been seven months yet since Labstyle submitted their 510k has it? Be patient. I think the BG1 got speedy approval because it was similar to the previously approved BG3, though the newer device requires batteries, I mean just begs for 'em. From the BG1 application:

      "The iHealth BG1 is similar with the predicate device iHealth BG3, the two devices are both for single patient use, they use the same test strip, and can test the blood glucose at the alternative site. The hematocrit range, the altitude and the use function are all the same. The appearance of the two device is different and both the two devices have no LCD display, they must be connected with iOS device, however, the connect methods are
      different, BG1 connect to iOS device through earphone jack, while BG3 connect to iOS device through 30-pin dock interface. iHealth BG1 use battery as power source, this is different from the predicate device BG3 which is powered by iOS device connected to the meter.
      "However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness."

      Here's a few recent tweets from @kenpardue (now I can better understand your concern for extra batteries... not that Dario uses any)
      July 1
      @iHealthLab Absolutely! I've been entering my BG readings into it in anticipation of getting the Align next week. Love what you guys do!
      July 11
      Hmmm, been using the iHealth Align for all of one day and I'm already getting Low Battery errors. I wonder if they shipped me bad batteries?
      July 14
      @iHealthLab using the new iHealth Align. I keep getting "Error: Battery is Low" messages sporadically, even when the battery is 1 day old.
      July 14 ihealth lab response
      @kenpardue Can you DM me your contact email and I'll put you in touch with our Customer Support to get you new batteries?
      14 July
      @ihealthlab Sure thing, but I'm wondering if it's even the batteries, as I've replaced them and still get the error.

 
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