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anyone know where this is currently at w/ the FDA?
We believe that Dario™ will be classified as Class II and we made a 510(k) submission for the product on January 7, 2014 accordingly; however, no assurances can be given that it will not need to undergo “de-novo” review or be classified as Class III device requiring a PMA. Both the 510(k) clearance and PMA processes can be expensive and lengthy and entail significant user fees, unless exempt. We will follow the commonly used industry practice, including those described in the new FDA draft guidelines for glucose monitors for self-use, “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use”.
As mentioned above, to obtain 510(k) clearance for Dario™ or any of our potential future devices (or for certain modifications to devices that have received 510(k) clearance), we must submit a pre-market notification demonstrating that the proposed device is substantially equivalent to a previously cleared 510(k) device or a pre-amendment device. The FDA’s 510(k) clearance pathway generally takes from three to twelve months from the date the application is completed, but can take significantly longer. After a medical device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a significant change in its intended use, requires a new 510(k) clearance.
Heard that! ECIG = Destroyed, thank goodness for other plays. Like DRIO!
I would say We are over due for a run here...
Maybe soon...
Was VFIN here today putting up walls?
Does anyone know the DeNovo number for this filling?
Anyone know the DeNovo # for the FDA submission of the Y-90 RadioGel(TM) device?
Good to hear!
GL!
Yeah, that is what I'm leaning towards as well. Little late (to close to FDA, etc.) and I do realize they have skin in the game as well. I was just seeing what some people thought - as in terms of the R/S or pulling some move out of left-field.
I really am not sure. I don't think they would pull a R/S; not at these levels anyways. Will see what happens in the near future - I do know they have a lot riding on this FDA approval and $$$ has been a sore spot as of recent. So, I could see them doing anything they have to, to keep this thing alive. With that said, I, could see them looking for a buyer overseas and/or merger over there. If, and I mean, IF thing's do not work out here with the FDA this time around....
GL
I don't think they are. Just thought it could be a possibility and wanted to get the opinion of some on the board. I've seen it done in past companies in these types of situations (recent run, float about locked up, etc).
IMO R/S down here in penny land are not good for shareholders.
GL
If the float does become locked up what do you think the chances are these guys initiate a R/S and hammer the price back down?
None of that will happen till post-FDA news.
Finally, had the chance to read thru the 10-k. My outlook and play on this company has changed. Obviously IMO, this thing just went from a swing play to a long-boring-hold play. I never really gave it much of a thought this could be a long-term play, as most plays down here never are long!
After reading the reports, this is a real company. With real attainable goals in mind. With that said the next few quarters, perhaps all of 2015 and parts of 2016 the Executive board could care less about it's share price - they are doing what they have to fundamentally to survive and generate sales. Not to mention do what's needed to finance the company...
When the time's right and the basic's are cleaned up. I'm positive they will then shift gears and focus on the share price and the shareholders. Till then, ECIG share price is in for a turbulent test of time!
With that said - I will be marking this as a long play. Will not be on the board much, or, watching it's movements anymore. Best of luck to everyone! And, great chatting with some of you on here! Again, best of luck!
Today's action, baffling to say the least, all sell's:
4/1/15 action of DKTS -
1,151,000 @ .0008 = $920.80
1,576,189 @ .0009 = $1,418.57
Total: $2,339.37
Well if it was intentional, which I'm sure it was. Don't you think it was effective? Look at the reaction just at our small group of investors here on the hub. Think about it Mr. Tbone. We have been a highly talked about and watched security for a small time now. Every move that has happened practically since the fall back in the 2nd half of last year has been watched.
Now, with the mini run we have experienced, the vote, the RS, the diabolic fall after the RS, and now the HEAVILY anticipated already once-delayed 10-K report. I say, why not hold onto it as long as legally possible?
I read just a few minutes ago that their was heavy short volume today and we still close in the Green. Think about that too for a moment, and oddly enough that fun-fact happened to be on the day of the infamous report is to be released. But, it wasn't for whatever reason.
Just speculating of course. But I say, why not wait till the last minute to show your hand? You know why they say,
"that's a vet move"
Because, of two things. 1) Experience 2) Knowing the rules of the game, every detail, specifically the obscure technicality ones. And, knowing when and how to use them to your advantage.
Putting it all together for a quick moment. Knowing your companies situation with everything that has gone on, blah, blah, blah. Knowing that this 10-K is not only heavily anticipated, it is a pivotal point in terms of what direction the company will be headed, and knowing that your company has/is a lot of attention on it; from wall street to main street...
I say, why not wait till the last moment...it look's like a Vet move to me.
Wow!
If that's not a tall-tale sign, I, don't know what it is. With that noted - I say to all longs and nervous investors. Enjoy the ride the next few days. See you on the other side!
Ugh, just logging on for the first time today. Where is the 10-k that was expected today?
Did I miss a PR about it?
Whats up board? Made it back in this AM, looks like it has been a heck of a ride lately around here? Congrats to all that have held since trips. Best of luck!
I hear ya there. Hopefully it's not a long road to recovery.
It's official I have no idea what to think anymore on our beloved ECIG. Pre R/S I thought I had a grip on things. But since then I cannot figure anything out. I also have not a clue what to expect in this 10-k later today as well...
Not sure if this thing is just getting beat down because of the RS and shorts? Or, because people are just panic selling and dumping? Or, is it the 10k really does suck and this bottom is about to drop off?
At a complete loss...
GL to everyone
Safe to say $NHMD has room to run if she had the right news and buyers around... #Pancakes in a can! pic.twitter.com/ChTNQh8DuW
— Swing Trader (@SilverFondler) March 30, 2015
is it safe to assume then we really will not see much price movement. till this machine is turned on?
legit, theory & logic right there!
We are back to 2014/2015 lows before the r/s. Right in the neighborhood of .05 a share. Large drop, if you ask me - one, that I suppose was expected. IMHO this was also a calculated drop after the r/s. To what extent? I just do not know at this time.
If we close lower than where we are - we will be at an all-time low for ECIG. At which point, I, believe chapter 7 discussion's will be on the table. There is no going back...
However, I, digress - IMHO again this drop after the r/s could have something to do with the conversions & debt. Allowing a small window of opportunity for those in the "inner circle" aka debt holders, etc. To either convert and double their stake in the company and/or allow those same people to buy up shares on a discount in the open market. All the while by forcing weak hands to sell....
This all depends on the 10-k. If it's a solid 10-k then the above scenario for better or worse checks out. If it's a bad 10-k well then, i think we know how that story ends...
Bottom line, the movement and the timing of this company the last 4-6 weeks have been unwittingly precise IMO. It seems as if a bigger game plan is in motion here, along with a little luck. It will work out for them and us (shareholders). Time will tell!
GLTA!
Great post, thanks for taking the time and sharing!
Been "loosely" following this company for a few months now. Any new news or incoming events/reports coming soon? Essentially anything looming that would make it worth while to take a position right now?
Thanks.
Any upcoming events/news around the corner? Looking to take a position with Hansen.
Looks as if they are continuing all their research and trials - at least w/ Mayo Clinic.
Looking to jump back in. Question is, what are your thoughts on the current price? Will it trickle down a little? Or is this steady and holding?
Thanks.
Hit it or maintain at that level?
I thought i read or received a message about there online sales starting some weeks ago?
Any actionable updates?
Soooooo
Where is the product and sales?
I have scottrade too. I would just calm down and wait it out. Focus on another play for a few days, this thing here at ECIG needs to settle down before any logical moves are made anyways. So enjoy your time!
Awesome to see you guys making strides! I sold my trip sevens a few weeks back at 12s. Best of luck!
Right, I totally agree having an exit plan in my mind. And, now moving forward I do. And it has worked great - thus not being in this kind of situation.
It is a penny stock. It was trading somewhere around .002 when I got in. It is now dancing around .001 and has from time to time touched the trip's.
I would classify myself more as a trader than an investor at this point. I am not a day-trader. Swing-Trader would be a better classification of where I fall into in terms of trading.
My timeline is wide open. Nothing set in stone. Nor is this a make it or break it type of trade in terms of cash flow.
Thanks for the suggestions!
Classic Rookie mistake was made. Essentially, over-eager, excited, to much hype, not enough DD type of BUY was made. Well, for lack of a better word...Duhhhh!
The question I have is. What is my best option in the following situation?
Made a poor, "price entry" when I first started. It's not breaking the bank by any means. However, in that particular position I'm at a 55% loss currently. Never sold for X, Y, & Z factors - call that a rookie mistake too. (Never been in that extreme of a situation before.)
Anyways, my questions is. At this point should I just sit tight and hang on to my debacle? Or, do I pull the chute and take the loss?
Any guidance or suggestion would be welcomed!
Thanks.
*I actively trade other positions, etc. However, I'm at the point now where it's just annoying seeing this big, fat, red, 50+% loss, every-time I log on!
Read the sticky he outlines it well.
Exactly, you know some old-school business tactics were at work. Whoever this financier/institutional guy is, waited to the last possible minute to throw his deal at these guys. One, to take a look at the books. Two, create time to do exactly what happened today to the stock, create a buying opportunity.
Then boom. Enjoy the benefits of this deal on both sides of it.
GLTA
They are restricted in terms of when they can be, "converted" or "dumped."
Favorable financing (debt/restructuring) for the company and ultimately the shareholder. Not a death spiral of toxic financing as most pinkies opt for.
Essentially, reading thru the lines. A big time (institutional) investor just bought up a lot of their debt.
And, with all that is going on. One could speculate that this institutional investor and a good look at ECIGs financials...
If all plays out. Tomorrow and the rest of the week we are in for a treat...
LOL, fair enough. Just wanted to give a proper sign off. I have been participating on this board for 8 months. Time to move on and dedicate my time to positions that actually make $$$
Like I said though - I will most likely sit on my stake and either ride it down to a big fat zero or let it take me to the promise land. But as far as checking on DKTS and continually doing DD. That is over.
Best of luck!