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Yeah, but that means no more DD from Bust.
WOW. .08 at open. this is going to get ugly really quickly...
It's obvious that the stock tanks tomorrow. But I'd be very surprised to see it hit .04 or .05. I think low teens or high single digits are what we are looking at.
The thing the market hates the most is uncertainty. At least we know SOMETHING now, as opposed to being in FDA purgatory.
As much as people have been clamoring for a consultant to be brought in, you all now have your wish.
Anyone going to be buying tomorrow?
No third party review route
For those of you all who are not facebook friends with Dean, he has officially shot down going the third party review route for the time being since we haven't heard anything back from the FDA.
Hi Benny,
Thanks for all your DD on this board. Do you have a link for the applications that took 160 & 183 days? Wasn't the 183 day application also a radiation emitting device? I'm curious as to its complexity.
Because one of the things with the DViS is that there are multiple predicate devices it is being compared to, which in my opinion would explain why it has taken so long. Do you know if the 183 day application was similar in its versatility?
If not, I'm curious as to why you think we may get approval before 183 days.
Thanks.
(I don't want to get my hopes up as we've passed 30, 60, 90, 150 day windows so far this year.)
Thanks!
17,000,000? I think we can definitely test $3- $4 post approval now.
GLTA
I think Shaka poses a very good question. With the number of investors like Bust and myself who are in this stock for the long haul I really can't see us going back down to the .04 level if the FDA renders a NSE decision (which I think is unlikely at this point given how long they've been reviewing the application).
I think the teens is very likely. I'd be VERY surprised if we saw single digits.
The WORST case scenario is that the FDA returns a NSE decision and we're forced to go down the PMA route, even though I'm not sure that route even makes sense for the DViS. How long would it take to go through that process? A few months? I think those of us holding long-term can afford to wait that process out.
I'm with BennyJ, I think we're maybe a week or two away from hearing approval. If not, I think the worst is we'll hear the FDA ask for some AI.
The volume yesterday was 6 million on no news. Does anyone remember what the daily volume was last year when it ran up to $1.95?
Given how frenzied and irrational the market can be, what do you all think the price will look like the day of and the day after we receive clearance? I think $3 or $4 would be entirely plausible. And I wouldn't even be surprised at $5.
BennyJ, the 2010 statistic doesn't deviate that greatly from 2009 and 2008 statistics. 2008 - 98.6% and 2009 - 99.2%. Since we're still here, looks like the DViS was in the 1.4% and .8% those two years. And am I wrong in reading either your synopsis or the PDF wrong? It appears that in 2010 after 150 days, in 100% of the cases a decision was rendered. It seems that your post suggest 510k clearance 100% of the time after 150 days in 2010. A decision rendered is definitely not the same thing as 510k clearance since the decision could be NSE.
Thanks for all your DD on this board though.
Can you name the seven other stocks you referenced?
This is some GREAT information (as your other posts have been). Where are you getting this stuff from?
According to Dean's facebook, that post was in fact written by Dean.
Don't forget Dean.
I, like most investors, was pretty bummed to hear the FDA was not able to open up the images. This was something that would have been understandable to hear a few days/ weeks after they received it.
But months after they received the submission? Just goes to show the inefficiency of the government bureaucracy...
Good luck to all longs. Hoping to hear approval soon.
Can anyone give a legitimate reason why we are seeing what we're seeing today? The Money TV spot was available for viewing on Friday and we saw what happened. I don't see anything new since Friday that would cause the massive sell off we're seeing today.
I don't think the LMAO comment was in reference to the share price. It may have been in reference to another commenter's post. You should just friend Dean on facebook yourself.
I am sure there are a number of posters to this board who are facebook friends with Dean that can verify that these posts on his facebook are indeed authentic.
From Dean's facebook:
Just goes to show you how people hear what they want!! The money tv interview gave out ongoing news and some think it's negative!! (1 hr ago)
LMAO if this thing dips any lower I'm going to buy more!!! (47 min ago)
Let them bash, the SEC is watching now!! (6 min ago)
Don't worry doc. I had a similar experience with IMGGorBust last week. I don't think we're alone either.
Unless there is something very significant, I don't think Dean will be doing another video update. This is from Dean's facebook last week:
"As I stated in my last video I won't be doing another video update and the investors forum will be removed as it went way to negatively viral. There are places like bulliten boards for that. I'll provide an update when I have something to report."
So here's hoping the next thing we hear from Dean is a PR stating we have FDA approval.
I hope we don't get into wild conspiracy theories here. At this point, there's no real use trying to guess when FDA will render an announcement as it seems that they are operating on their own timeline. Can't remember the post, but I saw on this board that Vermillion submitted their application in the spring and didn't get their approval until the fall.
The only reason I brought up the labeling issue was because the atmosphere was somewhat similar to where we are now. We all thought approval was imminent. Then, as you cited, we got a new CDRH. All I'm saying is that it's possible something else could come up (which might explain the wait). You yourself even said, "that should be it." I agree.
Bottom line is that no one knows when the FDA is going to render a decision as they seem to be operating on their own timeline.
Here's hoping we get approval soon.
GLTA
Couldn't have said it better myself.
IMGGorBust, I want to reiterate (since my post was deleted) that kimble was a long time investor in IMGG. She used to be one of IMGG's biggest supporters. Like many (not all) of your posts, they seemed to be very credible.
They stood out from the sea of people who, like you said, made comments like this stock is going to $20 and we're all going to be rich. Why wouldn't I ask her her assessment?
If for some reason you decide to bash the stock in the future, does that make everyone who currently seeks your opinion a basher? No.
My position is NOT a short position.
Thank you!
I hope this message doesn't get deleted also, but the main point I have been trying to make is that none of us know when the FDA is going to make their decision.
Like everyone else, I say the sooner the better.
But how can you infer that the request for an electronic copy was for the final decision as opposed to allowing the reviewer to use the electronic copy to consult with other reviewers?
Considering the FDA acknowledged receiving the submission on April 9th, either requesting or receiving an electronic version on the 23rd (only TWO weeks!), I think it's more likely the electronic copy was requested for real-time collaboration. It would seem a bit absurd to me if the decision was rendered and here we are nearly two months later still waiting to hear from the FDA. (With most of my life's savings invested in IMGG, I would love to be wrong about this.)
Talk of a PDF and a lawyer accepting shares for payment is irrelevant to when the FDA is going to make their decision. As Dean has stated multiple times, once he hears about approval/ clearance from the FDA he will immediately send out a PR. Judging from Dean's facebook statuses, he's as in the dark about an approval date as we are. Any "hints" or "trying to connect the dots" beforehand to guess that approval is imminent is simply wishful thinking.
IMGGorBust, I watched the same video and am a bit bewildered at how you came to your conclusions. The video stated that an electronic copy allows the reviewer to send copies electronically to any consulting reviewers immediately, allowing them to do a collaborative real-time analysis. I don't see how you came to the conclusion that "the FDA only needs the electronic version to enter into its system UPON approval." Please elaborate?
Dean stated that the FDA acknowledged receiving the submission on April 9th. According to Dr. Polk on the Yahoo board and confirmed by gdsgds on his office visit, the FDA asked for an electronic copy on April 23rd (or did they acknowledge receiving the electronic copy on the 23rd, I can't remember at the moment). Regardless of which, that'll be two months come next week.
Are we really to believe that the device has been pretty much approved/ received clearance for nearly two months now?
Secondly, I wouldn't read anything into a lawyer accepting payment in a penny stock for his/ her services. He or she is anticipating approval as we all are. But that has nothing to do with our FDA status.
I've been an IMGG investor for almost a year now (and the market backs up my assertion) that we all felt approval was imminent in November, when Dean stated the last request he recevied from the FDA was a one sentence labeling issue.
Unfortunately, we all know how that turned out...
The production value reminds me of Money TV! Maybe that's a good sign for us. Is it just me or does the intro for Money TV look like it's been unchanged since the 80s?
Kimble,
How do you know all the current questions the FDA had (18 or so?) have been resolved via conference calls? Did you have a conversation with Mike Mike Nessen or someone at IMGG about this?
Kimble,
I have been following your postings for some time. You've been one of the most reasonable posters on this board. You felt that upon approval Dean would sell for $2/$3 share. What has made you change your mind to sell all your shares for $1.50?
Thanks.