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Does anyone know what Dario-Lite is ? I just saw it registered as a trademark
https://trademarks.justia.com/867/22/dario-86722227.html
No one reads a company's 10k , does research on their competition and keeps updated on everything the company PRs for over a year just for a "good laugh now and then".From a person who seems to be reasonably smart as proven by their google searching skills we are just not buying that.
That being said iAlign is a toy that needs batteries and shows fake/incorrect readings and wastes strips.They need to redesign the whole thing to make it marketable in the long run.Its the "future" as in they are not here yet. Maybe due to the mistake of approving products like Align is why FDA is now stricter with Dario.
If you have followed any ticker that had heavy warrant conversion followed by r/s then you should have noticed a huge surge in pps just before the split. It however always falls down post r/s . Check AXPW. Expecting the same is AEZS in the lead up to 17th or before the r/s takes effect.
"As has been pointed out, Amazon reviews are unreliable evidence"
This is like saying all Airbnb rentals are rapists or all uber drivers have criminal records.
"MORE important, the Align has been on the market for OVER a YEAR now."
And they are not doing that well. Walgreens dumped them with others to follow.I did not find iAlign in walmart.com. Not there.
Dario is waiting for the FDA approval for marketing the product on a bigger scale.They have really worked hard to get to this stage in the approval process.If you are not interested in the product why hang around here all year? Why read their 10-Qs with so much interest?
You need to reveal your motive here.
"First, you have no evidence to support any assertion that the Align is a piece of junk"
Yes I do, its in the Amazon reviews .You can't prove that it is not a piece of junk, No sales numbers, No company names, Only guesses that someone is buying them.. Weak arguments every single one.
"a diabetic could buy a trunk load of lithium batteries for spares!"
LOL.
You either work for iAlign to call it the "future" or sell Li batteries by the trunk load.
See the review from Amazon below, it's recent and user calls it absolute garbage and a piece of crap.
1.0 out of 5 stars
Absolute garbage. The tester comes with 2 batteries
By Bill on June 2, 2015
Verified Purchase
Absolute garbage. The tester comes with 2 batteries, the first battery dies after 3 days and the 2nd battery died after a week. Even when I unplugged the tester and put it in it's wrapper band after every single test. Also, the Droid app that you use with it crashed and lost all of my testing data. I was being very good about testing before and after every meal, and then this product screwed me. Piece of crap.
Sorry from what I read about this product it looks junk.
One more thing I read on the multiple 1 star ratings . You have to scan the bottle of strips before using.If you manually enter some readings it assumes you used the strips and won't let you use the remaining strips and asks to scan a new bottle of strips. RIDICULOUS!.
Guess 30-50% cheaper strips don't make sense now if you end up wasting strips like that plus it also wastes a lot of strips with incorrect readings.
Only thing you are right about is that it is Cheap as in cheaply made.
Myth busted...moving on...
None of these makes any sense.This is 2015 not 1990.
If Amazon reviews are unreliable then "whoop te -doo" opinion is worth same as a POS.
"Align is backed by one of the largest medical suppliers in China"- someone believes in Chinese companies LOL! Which one?
Show Sales figures or go home!
"so I guess someone must be buying!"
Do some research and then come back on how they are selling otherwise do not try to pitch some defective product here.No guesses post facts!
And so is Amazon Fire phone compared to Iphone . People would go for something reliable and cool compared to a piece of junk that needs battery replacement every few days.
http://www.amazon.com/iHealth-BG1-Align-Glucose-Monitoring-System/product-reviews/B00N4T3CRM/ref=cm_cr_dp_qt_hist_one?ie=UTF8&filterBy=addOneStar&showViewpoints=0
If you are guessing hmmm why are they not drawing power from the audio jack like Dario and avoid the whole battery fiasco ..well that is where
"A patent isn't worth a DIME if NOBODY wants what's being patented! " comes into play.
Did some research on the stated "bigger picture"
1. Requires Lithium ion batteries to run .Very new age
2. The quarter size device definitely wont carry the strips within so you have to carry lancets and strips externally.
3. Amazon has 3 star ratings overall with many complaints on design, software and losing connectivity with the phone during reading if phone has power save mode.Many one star reviews complain of weak battery warnings, running out of batteries frequently and device not working all together.
Now lets come up with their sales numbers to see if this is indeed the "bigger picture".
Funny I have never heard of it or seen it at any walgreens and I have been to a few recently. Anyways since you are good with numbers what does their sales figures look like since they have been around for more than a year. Are physicians distributing these like candy in the clinics?
Analyst rating of $3.5 near term is bringing the volume
http://finance.yahoo.com/news/global-rollout-labstyle-innovations-dario-070000565.html
LabStyle Innovations Closes $2.5 Million Funding to Support Global Rollout of Dario Diabetes Management Solution
Investors include company officers, employees, friends & family; Participating high net worth private investors include current shareholders and a new investment by Shmuel Farhi.
When insiders, friends,family , current shareholders and high net worth investors are pouring money into a OTC stock it means that the company is going in the right direction. You will not get investors jumping in and buying shares for a sinking ship.Also it means that FDA approval is very close.
No kidding. Dario is an OTC stock with pps of $0.31 . Do you really believe that this company should be a no risk at this point of their existence?
They have a finance issue which is why it is trading where it is right now but the product is great and the management has also been great this year.
They are looking to capture a share of the Diabetes market so they don't have to be the best product out there Although they are the best right now with the mobile centric glucose meters.
Also since they are mobile based I am not sure how Windows10 is significant .They will do ok with the apple and andriod markets for now.Most other meters don't even have android app.
As for China and India Dario ha much higher chance of making it compared to Dex with the price point. The recurring costs of lancets and strips have to come down to penetrate these markets.
Apple watch is a toy right now. Until it becomes a serious device there is no point spending resources for development.Most Apple watch users have the iphone so it is pointless.
Time and world economy right would be supportive of Dario because of the low cost and the ease of use.I don't know what else you would buy.
CGM has existed for a while heck Dexcom CGM also has already existed for a while now. The FDA news was for G5 version of their CGM.
Shares for Dexcom went up a whopping 5% on approval.
Dexcom CGM G4 Platinum has been around for a while.Do you know the cost of this system?
Let me save you the trouble. It is only $1200. G5 will be priced more than this.
Sensors stick to your body 24/7 to be able to transmit via bluetooth. One sensor lasts a week before they need replacing.
Cost of a 4 pack sensor? ...wait for it ...$349. That's the monthly cost for the user.
Sure its a superior technology but it is very expensive and there are also other companies currently in the CGM space. The market for CGM is different than market for Dario.
Dario is not aiming to capture the entire market for Diabetes only a part of it.
Also I'm not sure how many people in the US qualify for CGM through insurance.
Please try some other gimmick to scare us.
I would like to please hear some details on the scam.
Can you enlighten on what the expected earning is? I don't remember reading about expected earnings in any communication from Labstyle.
No one can control when the FDA chooses to approve anything. Everyone's estimate is just that..an estimate.
As for McGrail if you do some research is a consultant who handles the FDA regulation for blood glucose devices among other things.He was added to ensure that the process of submission and anything related to the submission goes on smoothly.Adding a consultant who has gone through the entire process for similar device is a smart move for a company that heavily depends on the FDA approval.I am sure his bonus and stock options depend on the successful completion of the FDA process as with other execs in Dario.
The announcement you refer to was made on March 18th before the application was submitted .I am positive that he was involved much before that for the submission process.
Their facebook page proves that the device is being well received and very useful to diabetics.I haven't seen any complaints about it recently compared to a few months back. Also their support has been top notch in replying to questions and getting new users their devices and supplies.
Revenue should keep improving from here on.
Their facebook page proves that the device is being well received and very useful to diabetics.I haven't seen any complaints about it recently compared to a few months back. Also their support has been top notch in replying to questions and getting new users their devices and supplies.
Revenue should keep improving from here on.
The company has 20+ employees and burn rate is high.Funds from the last dilution in March 2015 would last till July 2015 so we are expecting another round of dilution soon.
Dario was in soft launch mode for a long time. Only recently they seem to be getting more popular in Australia and UK. Marketing for the device is still non existent.
In a nutshell funding and inventory are the major problems for Dario right now that limit the pps.
Dr Edery was the principal investor in October/November 2014 and now has 2 board seats represented by Dr Kash and Hila Karah.
CFO, Zvi-ben David and Board director, Prof. Stone, participated in last round of investment in February 2015 with more than a million shares each.
They will do their best to prevent a R/S.Its all there in the previous 8ks.
They increased the limit of O/S exactly to not do a R/S other than for uplisting on Nasdaq.
Expect dilution.Many insiders got in on the last round and so the likelyhood of R/S is low.
Dilution for 3 more months of spending cash will happen most probably no way they will do r/s before the approval.
What happens if I use a tablet and when I change my smart phone every year or sooner?
A different case for each phone model sounds ridiculous rather than interesting.
FDA approval process
I did some research on the 90 day FDA approval process. Although FDA claims that it requires to respond to all Device 1 and 2 510k submission within 90 days it may and usually does take longer for them to approve. Their average is a little above 4 months.
I would not hold my breath for the FDA approval by June 24th even though it could happen any day now.
He is talking about the 8k out today . It says the Company received gross proceeds of $461,673, and issued to the Buyers an aggregate of 1,923,636 shares of Common Stock and Replacement Warrants to purchase up to an aggregate of 1,923,636 shares of Common Stock.
This is from the private placement in Feb and March. Nothing new other then they got some operating money.
Look at the Market Cap. It's too low for a company that is so close to a FDA approval.
Also the last round of financing had some insiders making investments.
The results for the study shows good results that exceed the requirements from the FDA.
These are strong reasons and not just air.
I would suggest you spend some time to read on past news and do your own DD.
You say its up 100% but its down from the post split price in November of $0.5. Lot of room to run up from now to approval.
Anyone who can read knows this info.Its all out there.
The stock price has been up 100% since last dilution.What do you have to say for that?
Read this
http://finance.yahoo.com/news/labstyle-innovations-submits-data-u-134500779.html
Second paragraph in the link
"We are very excited to have completed the submission to the FDA. The successful study shows that the Dario™ Blood Glucose Monitoring System is highly comparable to its predicate device and can be a valuable tool to the U.S. diabetic community," stated Erez Raphael, President and Chief Executive Officer of LabStyle Innovations. "The Dario has already received marketing clearance in Europe and has launched in the UK, New Zealand, Netherlands and Australia. We anticipate approval and launch in the U.S. in 2015 where the glucose monitoring market is expected to reach $12 billion by 2017, according to the International Diabetes Federation."
It was submitted on March 24, 2015.
There is only one FDA application for the device which is the link that you have posted.There is not going to be any other FDA application required.
The annual report came out less than a month back so I would guess not for at least 2 months
WHITE PAPER:
PERFORMANCE EVALUATION FOR DARIO BLOOD GLUCOSE MONITORING
SYSTEM ACCURACY EVALUATION
http://mydario.com/wp-content/uploads/2015/04/MK-0010-Rev.1-Performance-Evaluation-for-Dario-Blood-Glucose-Monitoring-System-New-white-paper-Clean.pdf
No .It got down to 109k before close. It was too late in the day to eat up that kind of volume.. should be gone in the first hour tomorrow.
"So far, the ONLY thing they appear to have applied for is the app" ...what else would they be applying for with the FDA...non sugar candies for Type I?
"suggest skepticism"... can cost someone almost 100% gains in the last 2 weeks.
"until you actually see the dario listed on the FDA site"...It will be too late to enter at that point.
Meet the Swiss Army Knife of Diabetes Meters.
http://www.diabetescare.net/authors/andrew-stivelman-tech-writer/meet-the-swiss-army-knife-of-diabetes-meters
Feels good to be back at around $.30.Great follow through and decent volume so far in the last few days .Once this blasts through the 30s the climb should be much faster.
It must be a bad day when both stocks that someone bashes regularly are up 20%. BTW the gain on this one today from last Monday(0.18) is 47%.
Some "Real exciting stuff!" happening today. Still in "the Nile"? or busy digging up for more dirt and don't forget to buy a new logic book.
In today's news DRIO is drifting lower from $0.18 after the release of 10k. This is happening because "no one knows OR cares whether DRIO even exists anymore!" and because "the 10-K isn't likely to attract any INTELLIGENT investors into the stock".