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Thanks for the chart and info.
SLXCF - Took a nose dive since Friday. Can somebody post a chart of it? Whats it expected to do? Thanks.
I've only been in for a year, but I still agree with madtig on this. I can remember at least three "by weeks end" or "ALL ABOARD" moments we've had since last September. Keep a cool head.
Ctrl + R are going to get worn out on a lot of keyboards this evening...admittedly mine as well.
That's actually somewhat incorrect. The FDA does state that it has a "Performance Goal" of 60 days. It hits the goal the vast majority of the time (90% in 2007). Also, it states that "the submitter may request status reports every 30 days following the initial status request".
Table 1. 510(k) Performance Goals
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089735.htm
Wouldn't count on weeks until buyout. If this process has taught us anything it's that things take time.
Congrats to those who got in on that dip...that was a quick recovery.
Thank you. I missed that.
Agreed. All of the cheerleading around here gets on my nerves sometimes, but talking about flipping off the CEO? The same CEO who has made people on this board millionaires.
Where did you get $20k? Nowhere?
Agreed. In posts 11174, 11179, 11183 I said to expect for end of March to be the resubmission. And people jumped on me.
Kimble was dead on. Impressive.
In chronological order:
Chemic: "Continual PRs , not helping.... as far as I'm concerned; makes me wonder what is going on. Don't hear any thing for the longest time, now bombarding with worthless press releases. All I want to hear about is the FDA process, not twitter, stock preacher , or money tv, thankyou"
Becky Krames: "The purpose of the call is to update Shareholders and other interested parties of the current developments with the company’s 510k FDA submission."
Chemic: "Once again, a regular market wire PR wuld have sufficed; all this drama leads me to believe that there is an unresolved issue regarding the submission. I personally would like to believe that every thing is hunky dory but am, I must admit a little skeptical about these after hour CCs. Either Dean has resubmitted or he hasn't there is NO gray area here, therefore no need to play the CC game IMO. GLTA"
"I just think it's irresponsible to conjure up all these negative scenarios when there's no reason"
I see that word being thrown around here a lot. There is nothing irresponsible about offering the scenario that it might take a little longer than he originally projected.
"I'm saying we haven't even come to the end of Dean's projected time"
Actually we have, as of tomorrow. I am not being negative. The glass is not half empty for me, it's just there...at halfway...and if it's a little less than half or a little more, I don't care, because I'm holding. Being overly optimistic results in everyone freaking out when those expectations are not met (30 days, 60 days, etc). No doubt, next week, people will be posting about why we have not had submittal. Summary of my point: stop worrying about time-lines, deadlines, etc. If we get to the end of March, and we have had no update, that's when I would become concerned.
By the way, what indications are your referring to? (not sarcastic). I saw a response from Mike Nessen and some people talking about Dean's facebook page, but other than that what indications has there been?
Ok, I guess we will see. I'm willing to admit it when I'm wrong. Hope you are as well. I would like to be wrong in this case.
"Because this is at the end of the review process, I expect that it will take only 10 days to 2 weeks to get back to Dean with approval or a few more questions."
That would kick ass, but it's not going to happen. This is not the end of the review process. The whole thing has reset...new review team. New submission by this Friday will not happen. That would be great, but end of March is more likely.
People posting things like "March 17th for approval" is just bogus. Let's be honest, we've hit a speed bump, and it's going to take some time. This is a long hold, so treat it like one. Getting people excited over time frames leads to disappointment and subsequent bashing. Everyone, chill. Check back in a month.
Everybody should just be patient. It's understandable to have questions, but in all likelihood a CC will take place soon as in the past there has been one about every 1.5 - 2 months. All questions can be answered then. Dean Janes will describe where they are, the PPS will go up, and everyone will love the stock again.
Again. 30 days is a goal. Also they could have (and apparently did) request more time.
"A written letter for additional information usually requests a response within 30 days. If additional time is needed to gather the requested information, the 510(k) submitter may request an extension within the 30 days of FDA's request for information. The request for extension should state the reason and time needed to submit. The 510(k) may be deleted from the 510(k) tracking system if there is no response to the request for additional information within 30 days of FDA's request letter."
Where did you get this information?
I hope it doesn't stay on .666 long.
To me, as I stated a few weeks ago, it seems like they asked for an extension. 30 days is a goal. Nothing more.
Most likely you will just get an email when they resubmit...like they have done in the past.
Yeh, I don't need bells and whistles. Pinks, OTC, BB easy enough on that site?
Could you provide details why please? What are the fees etc.?
What's the best day trading broker site out there? Getting tire of TD Ameritrade holding my money. Thanks
What day trading brokerage do you guys use? TD Ameritrade keeps holding my money for too long...getting sick of it.
Thanks
Seriously, let's talk about tomorrow and next week. People are throwing the number .50 out there a lot for tomorrow. Can we start listing why? I would love to see that number. But aren't the "restricted shares" still scaring people a little? Provide some comfort here please.
Got in for .13 today after some funds cleared. Got my buddy in at .051 on Tuesday. He's happy.
What's the real time at right now?
You cannot trade OTC Bulletin Board securities during extended hours.
Disregard. I found the info I was looking for.
New guy here. Can somebody tell me what happened in Jan? Why the drop from $1? Also, what is expected in the near future for this company? Thanks.
Seeing how it was $1.95 just a couple of months ago. Doubt it.
As a lurker, the multitude of posts about deadlines (30 days etc.) are as annoying as the posts about IMGG "after hours trading". Neither really exist. If they requested more time, we would not know it until the next CC.
"Sorry for bothering you with timelines."
Talking about 30 days or 60 days (even if it came directly from Mr. Janes mouth) can make people panic...much like it did in late December. Hundreds upon hundreds of posts saying "if he submitted it on Tuesday then today is the day!" or "no, he probably submitted it on Friday so that would mean the letter comes tomorrow". Then when the letter/fax doesn't come that very day people freak out. That is not timeliness, that is impatience.
30 days isn't concrete.
They could have asked for more time. Especially with the radiologist review. People get too hung up around time frames here.
Who cares?
"Operative goal/guideline is 60 days". Agreed. I just want to guard against another/similar situation where people hear "30 days" (last CC), and then freak out after the 30 days is elapsed. I'm new to investing and don't have very much in IMGG, but it amazes me how fickle and fair-weather the mob can be.
"By the guidelines it would be 60 days". I don't ever post, just lurk. I keep seeing questions like "What will be the new review time for the FDA when receipt received by IMGG ? 30,60,90 days ?" and answers like "By the guidelines it would be 60 days, but as always, it could come much sooner."
I just want to point out, as it has been done before, that the 60 days is only a "performance goal" for the FDA. So, just hold and chill.
IMGGorBust, not a knock on you, I generally enjoy reading your posts.
TechStockBob. I've been following this stock for a month on a very occasional basis. I am invested in similar medical company, and am looking for another investment opportunity.
For the new guys, like me, can you post a brief summary of what is happening with the company right now? i.e. what has happened recently since the September run-up and what everyone is looking forward to in the near future for this company. Sifting through all the old posts seems a little daunting due to lack of time/energy.
Or if there are other posts that have already done this, please reference them.
Thanks in advance.