actually conducting DD
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This is worse than one could ever imagine.
What possibly made him hold this conference.
WASTE OF MONEY AND TIME.
FDA still reviewing!!!
BTW, its not legal to trade on inside information.
I have it on good authority that there will be good news, but not approval news, this afternoon.
I am done also.
Since approval may not come for a long while, the conversation on this board is just looping itself (guilty as charged).
Good luck to all.
On July 16th, 2010, IMGGorBUST said:
"I think we've passed the 90 days, but if they felt they were delayed a little because they couldn't open certain files then they will probably add that time in. It's any day now. I'm still good with that. "
Are these the types of "positive" posts that are helpful??
How can one not be negative
when the pps keeps falling
when the approval process marches towards four years
when the company refuses to hire help
to simply spin this downwards spiral into a buying opportunity is frankly sad
So why is the company so resistant in hiring someone to help with the process it has failed at????
No marketing. Understood. IMGG pulls out of RSNA.
BUST, you are not saying its illegal.
Since you are a regulatory attorney, please answer this question; is it illegal to post the requested images while an application for approval is pending? Yes or No.
You might include a verifiable reference, if the answer is Yes.
BUST, why dont you just load up on what's out there?
Why does the company need to issue new shares?
IMGGorBUST, who would be interested in new shares which would further dilute the already low pps.
its one thing to buy into the existing pool. its different to buy a new bathing suit for a pool that has only inches of water.
IMGGorBUST, for a regulatory attorney you should know that the word "generally" in any guidelines makes for lots and lots of exceptions.
One might say that the exceptions swollow up the rule.
We are creeping towards year FOUR. The CLOCK issue is a non issue.
Borntwice, isnt everybody here anynomous???
I do hope you win this time!!!
IMGGorBUST, the fact is
that as reported by the CEO on MTV, the entire package was resubmitted for some reason or another.
That means one of two things, either the FDA had sufficient trouble with what was in front of it, or the company thought that it needed to do it to make it better or easier, or whatever.
I think the history speaks for itself. It always does.
IMGGorBUST, are you predicting again???
Hostile takeover??
I dont think that the company has to worry about that.
The only hostility comes from disgrunteled shareholders as they watch the inaptness of managment in dealing with the application process.
It is a fact that the pps is going down.
At this rate, teens are a certainty.
IMMGorBust, please do not misreport posts.
I clearly used the words "non substantive changes" when discussing the problem with the application.
The point is, there is always some explanation.....
IMMGorBUST, you miss the point.
Everytime we hear from the CEO, he reports on how the application was resubmitted, corrected, amended with alleged non substantive matters.
If you cannot get the format correct, what chance does the applicant have when the substance is reviewed.
The company needs help. Period. Its not always someone else's fault.
Do not blame this delay on the FDA.
The blame is solely managment's inability to close the deal with the regulators.
Companies submit applications all day long to a miriad of state and federal agencies.
Sometimes they go at it solo. If they dont make the neccessary progress, or stall out, they will hire someone to help.
Obviously this managment is unable to get it done and unwilling to get help.
The only thing that anyone is currently interested in is, when approval is likely to come, based on the sufficiency of the information in the application and the types of questions and comments from the FDA review team.
Anything else is old news or no news.
Since the company is not talking, if anyone has that type of info, let us have it.
Its now FOUR months after resubmission and THIRTY DAYS after re-resubmission.
Looking at the last few posts
does anyone need any more proof about IMMGorBUST's "input".
I agree, ask the company and stop reading his stuff.
Well, not a bad or surprising end to the week.
With no news, there was bound to be a drop in pps.
The drop does not signify panic.
Next week, most will think/hope that news is just around the corner, will buy some more and back to 0.3.
Seems logical on the surface.
Could also be a defensive tactic.
Lets change the subject and get serious.
What are the realistic scenarious if approval does not come.
Can anyone describe a scenario that does not involve a significant loss in share value.
4 months since resubmission; 30 days since re-resubmission;
Time for an update Mr. CEO.
Thank you
IMGGorBUST, what is not good news is that the predictions comes from someone who has been predicting this for three years ++
The sky is not falling, the sky is not falling...
Dean Janes' categorical statements on MTV
did not relate to a time frame. They related to the certainty of approval.
What is everyone's understanding of Dean Janes'
statements on MTV about the application 'flying through".
Were his remarks not categorical in nature?
Based upon the last MTV appearance,when the company's CEO
expressed confidence that the application will fly through and approval will come, I kept my shares and decided not to sell.
It is now 30 days' later (based on the July 5th re-re-resubmission) and still no answer.
What are the legal implications to those categorical statements?
To change the subject,
The initial application was filed on June 15th, 2007.
Does anyone know if any application of this type has ever taken this long??
July 5th...last (re) submission...
To anyone in the real know ( you too Cindy) what is a reasonable time for a decision?
Someone remind us,
When did the company last (re)submit the package?
GoIMGG, we will hear from the FDA
on August 5th, 2010 at 4:17 EST, but I cannot be more exact than that. Sorry.
I am an investor.
On June 9th, your beloved IMGGorBUST predicted as follows:
"I fully expect we will get approval notice from the FDA this week or next. This close to approval, we should be running like a Kenyan. "
IMGGorBUST, thanks for the prompt response to my post.
The past conference calls have no relevance to what is going on today. (see, I used one of those legal terms )
The last MTV spot did not offer any details about the interactions between the company and the FDA. The CEO did state that it would/should sail through.
In conclusion, you live in the past, which evidences FOUR years of no results.
We have no clue about the present.