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http://www.moneytv.net/volume15week19.htm its up. no doubt about it. googled moneytv. this weeks show. real producer. broadband. first interview.
ACT is a Sales Management System. It has an stupid auto correct capability.
What am I missing here? "Only items under review can be demonstrated" looks ambiguous..."no promotion can be performed before the device is cleared for marketing". mmmm....not to mention the device is NOT under review at this time. Does it say somewhere that the device cannot be shown prior to submission?
Of course, that is a requirement.
Read the letter. Yes. It does NOT say the machine doesn't work. The FDA never saw the machine so they don't know one way or another.
Here we go----.158 green....today the day the re-rite is complete?
Does anyone know the name of the consulting company that is doing the rewrite? Not that the company would reveal they were working on this. But somebody must know somebody there that can get an inside look.
Promise?
A direct quote from your post..."Someone needs to get their facts straight but I know it's not me!!!" you know it's not you that needs to get their facts straight.
The fact is, there is a machine that works, MWE IS on board, their is a consultant doing the re-write to remedy the objections in the recently posted AI. Those are facts...but I know its not me that needs to get their facts straight as you revealed a few hours ago.
Nor did I. Another professional firm is to the re-submit. MWE is providing legal advice as required.
The company publicly announced the retention of MWE, a material event. The separation of the two would be a material event and thus reported to the public. Please note where the company has stated MWE no longer represent the company. Stick to the facts.
LOL, do you really think he cares about the current share price? The only thing that matters is where it going (up) not where it is today. Looks to me like everyone is holding or this thing would be far lower than it is now, so many early adopters don't care where it is now.
Could be, but not pertinent. The pertinent issue is that a sophisticated organization who does this type of work as their business is doing the re-submit. Janes may have a great idea, great product, but that doesn't make him a great writer that requires great attention to detail.
DrP, looks like this is a reply to Mugs comments, not reatimeimgg, correct?
long, he may have had other submissions, but it doesn't mean it was as complex as this. Reading the AI letter makes it pretty obvious he was in over his head as Polk and others have clearly stated. The big diff now is that professionals with contacts at the FDA are doing the re-submit and MWE is on board to make it all work. Mugs these are facts so please don't bother to re-but.
Homer, well said, recommended reading for all.
Why?
Polk has indicated if not directly, certainly indirectly he is a close adviser to Janes..."I begged him to get outside help for over 2 years". One can conjecture he has seen the unit operating if he has been that close for that long. He is likely unable to state directly that he has seen the unit in successful operation because he has signed an NDA. Just a guess but probably a good one.
Stockmaster, simply an SEC attorney/adviser making sure every thing is squeaky clean, nothing more sinister than that.
Maybe they haven't thrown in the towel but perhaps the face to face meeting with the FDA has occurred and the result is not good in the sense they are in for a long haul.
somebody can check it out, but the flurry of downside activity usually means something negative has occurred with public announcement some time later.
Imaging3’s CEO, Dean Janes, today provided insight into the Company’s strategy for resubmission to the FDA.
“After reviewing with our FDA counsel our prior application, files, images and recent FDA correspondence, Imaging3 plans to resubmit its application for clearance of the Dominion Vi Scanner under the FDA's 510(k) process,” stated Dean Janes, Chairman and CEO of Imaging3, Inc. According to Mr. Janes, “the results of our review with counsel has determined that the 510(k) program remains the most appropriate and efficient route for FDA approval. It was determined that the “De Novo” and “PMA” processes were not necessary and with some minor adjustments to our existing package along with some additional information and potentially a pre-submission meeting with the FDA, the 510(k) submission should be successful. I am confident that with the assistance of our newly hired FDA consultants and our new strategy we will be able to provide the Agency with a package that meets their needs to expeditiously approve our device,” Mr. Janes added.
If you have any questions, please contact Investor Relations by e-mail or by calling (800) 900-9729 (800) 900-9729
Sincerely,
Investor Relations
Imaging3, Inc.
Burbank CA 91505
No doubt there will be a PR soon. McDermott has been reviewing the package for two weeks now, likely has completed the review. It only makes sense their advice will be to resubmit, not appeal. (reportedly Janes' submission was a mess, right?) If they have the clout they say they have they'll try to get it on some sort of fast track, by-pass the lowest level review and start out at a higher level. A discussion between Janes and his advisors and McDermott logically should happen soon to finalize and approve McDermnott's recommendation. PR to follow that. That's why its running, it always does before some action. Simple logic confirmed by market action, don't you think?
a pr soon
Well who the heck is doing the buying? These buyers can't be fools at this investment level, can they?
200,000 @ .222, then 118,000 @ .228. Guess somebody knows something(???)
150,000 @ .23 just changed hands. So what exactly is going on?
Repair and refurbishment by definition IS manufacturing. Machines are dis-assembled, parts repaired and/or replaced and re-assembled. The process if done correctly requires written procedures, documentation of work completed and a quality assurance system, all recognized aspects of a manufacturing operation.The point is that it may not be directly related to the 510K, the FDA would be foolish not to look at existing manufacturing capability during the approval process just to be certain they are dealing with a legitimate and capable company. Let's not spin something that IS, into something that isn't.
Gee Sano, why would you think? The FDA is dotting i's and crossing t's. Do you really think they would ignore the company's manufacturing capability even if it is for another product? It would be pretty embarrassing if they approved a device then later found out the company had shoddy manufacturing controls for existing products, don't you think?
Polk or someone posted the "audit" was six months earlier than is normal signaling the likelihood of i-dotting and t-crossing. given all the criticism the FDA has had it only makes sense for them to do this out-of-cycle audit of the company. Approval has been signaled.
JB, excellent analysis. Look at the volume all of a sudden. This well may be the beginning of the run. what say you, Sano?
Sano, it doesn't matter if its a tidbit...it really happened, verified by the company. Another confidence builder. Why else would they bother with a manufacturing audit?
Sano, it could be zero production a year and they still could have well documented manufacturing procedures, a quality control system, a components traceability system, a purchase control system...all the things that make up good manufacturing practices. It makes good sense for the NEW FDA team to come in and review these manufacturing systems (not the actual machine assembly nor machine functionality) before they give full and final approval to the 510...don't you think? It is noteworthy they did this out of cycle, sure looks like a pre-approval move. No reason for them to come in now other than a final formality before approval. And its been reported in other places they passed with flying colors.
Do you think they would bother auditing if they did not intend to approve? No reason to have an early audit other than approval. keep in mind the prior audit was done by the prior FDA review team, not this team. Another crossing the t's and dotting the dotting the i's to invoke a cliche.
They audit the manufacturing/quality system, not the machine itself, btw.
SBW, sorry, you don't know one way or another that Polk is or isn't an insider. And you certainly don't know if someone else is posing as Polk. While he may have just created an alias on IHUB recently he has been posting on yahoo for quite some time. Ask Sano. Others on yahoo have checked out his credentials and report he is who he says he is.
It is NOT "obvious" at all that someone is "trying to perpetrate" a scam from this evidence. At the end of the day, this is an FDA play and not a scam at all.
20H20, LOL, no problem. Actually adds to my confidence that the MMs know the final value will be much higher and that approval is around the corner. The reviewer should be done this week and the sign off up the ladder is next. Selling 5k of more than a mil shares on hand is worth the "test" and confirms peace of mind from another angle.
BTW, again if any of you haven't read the article it is highly recommended. Forgot who posted it originally but a big thanks to him/her. the stock behaved as described in the article.
OOPS, my mistake, the linked article is #23678,
http://www.traders101.com/article-market-makers-1.asp
For what its worth I decided to test the proposition myself and put in a sell order at 14:26 when the ask was .25 and falling. Place the order for 5000 shares at .28. It was filled at 15:11 and 15:14 coming off trades at .26, .27, .273 and .278.
Looks to me like the MMs are grabbing everything in sight right now (within reason) maybe indicating another up day tomorrow barring any bad news. Pretty much like the article suggests. For what its worth.
BTW, they'll probably close it out at a lower number, .26, .27, not at the high if prior patterns hold true.
BennyJ...try this one...on the recent run down and other run downs the short interest was around 50% or so. The MMs were pushing it down (read the article linked in #23807)selling shares they did not own, knowing they would buy back at a lower price averaging their cost down.
After the CC with positive news it was time to take it up. They don't want to short it (34% short instead of 50%+)because of the CC or their black box or insider indication (they know Dean is telling the truth?) is signaling a higher price.
Test it out. Place an order just above the ask right now and see if it gets filled before the end of the day. If it does I think that lends credibility to this proposition. What say you?
There's nothing new to tell...the point of the CC was to reassure everyone that nothing negative has happened, that the process is still moving forward at the FDA's pace. that reassurance was important to hear it from the horse himself. In the absence of this reassurance the rumors would get ever larger in the negative sense.
Is that not sufficient reason to hold a CC? Works for me.
Not to mention he clearly stated the machine does exist and it does work as advertised. I presume other posters on this board are correct, that if that is a lie our man is headed to ClubFed.
see the message to sano I just posted. I don't know those folks at the company, they had no idea I was on the line, I had my chance to ask a question but it was "asked and answered". You can hear me as the second or third last questioner. No there is no set up on the call ins. Period. Put it to bed.
Sano, why do you say the CC is for "new information"? How about information, period. He gave us that...no need to go into financing for production, he has stated in the past and I think your pal Polk has confirmed the company will be sold quickly.
There is no new information.
the hardball question I was going to ask was does the machine really exist and does it really work, a couple accusations that keep coming up on these forums. Someone got the question in before me...I was the "asked and answered" at the end of the CC. I was pleased I had a chance to ask because it made it clear to me that the questions were not a set up that only went to friends. They had no idea who I was when I had my chance to ask the question.
BTW, it exists and it works as stated. The FDA delay is simply a new team dotting the i's and crossing the t's. Period.
I am on hold to ask that very question...now I don't need to...to be clear Dean stated the machine does exist and performs as he has stated in the past. Will this put that nagging question from the nay sayers to bed? Maybe his answer can be put on the top where it will always be there.