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"If this isn't enough, let us know right now, we'll provide more...."
What the hell is that supposed to mean? Shouldn't everything be in the package to begin with, especially if you dont want additional AIs?
NEWSFLASH!.......Dean's new strategy:
"We're gonna present it to the FDA in a meeting and say 'here's what we got.....you know, we're tired of this back and forth and question after question. If this isn't enough, let us know right now, we'll provide more and when we file this we want to get a yes'..... yes, they're gonna review it but we want a yes out of this.....I mean, it's been long enough!"
Holy crap, aunt Millie........load up the boat!
ARE THE OIL COMPANIES HOLDING THE U.S. CONSUMER HOSTAGE?
Since 1970, US consumption of Nat Gas has been level in spite of severly declining futures prices and a growing supply overcapacity. All the while, US consumption of oil continues to rise in spite of drastically higher prices amid a worldwide supply squeeze.
Can one draw any other conclusions?
Why won't the Obama administrastion mandate that all government vehicles run on Nat Gas, as Pickens advocates?
Someone give me some help here!
Vino......recall was for door cable wear. Sounds like no big deal......a heat shrink tube fix.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95240
Sano.......do you happen to know when Medtronics O-arm cleared the FDA?
Bye the way, next to the O-arm, the DVis looks like a Model T!
"Our extremely popular “FDA Plays of the Month” has yielded huge gains for our board followers." How is that statement supposed to be taken, besides trying to establish your expertise? All I am saying is, SHOW ME THE PROOF!
GLTA
But the reason you put the "tracker" on the board is to verify your expertise with FDA plays. Indeed, you boast of the supposed excellent results. However, until you provide the transparancy of entry and exit dates, I will remain highly skeptical of your claims. THANKS AGAIN.
PS: I'm surprised that your stop wasn't gapped over, or do you put a .55% stop on all your trades?
If CADX was the Nov "Play of the Month", then presumably you bought it at 9.03 on either 11/1 or 11/2, the only two days that that price level was available for entries during the month. Subsequent to that, the only time that you could have sold at 8.98 is on 11/2 as the stock gapped below that level the day after, and stayed below that level for the duration of the month. So, I am assuming that your CADX trade was a one day trade.....in at 11/1 or 11/2 and out at 11/2. But if that is the case, then the question remains why was your sell not posted till late in the month?
I think your "Tracker" would carry more credence if you posted the exact dates of your entries and exits, along wth their respective price levels. THANKS.
I'm new to this board and having trouble trying to make sense of the "Play of the Month Tracker" figures. For example, when did you sell CADX for 8.98 and when did you buy MNKD for 5.75? According to my charts, these numbers were unavailable at the times that you posted them. Any primers available on how best to use the content of this board? Thanks.
LOB.......if you read the article with the rose colored glasses off, you will see that Medgadget reached their indecisive conclusion after consulting the exact same resources that you and I have had access to, and have been debating the credibility thereof, for months. There source was Dean Janes. The truth is that they know no more about the effectiveness and safety of the DVis than we do.
Looks like the downsloping 50DMA and 20WMA are going to put the kabosh to the recent bounce. If there is no verifiable and confirnable positive news coming out of RSNA, and in the event of a closing break below the .157 area in the near future, then look for new 52 week lows as the downtrend continues unabated.
Lob......For what purpose? If he knows he can't post the "insight", then why post that he gained the "great insight"? It's Dean's modus operandi....... just a natural extension of the strategy to claim that you have a ground breaking technology in an existing and operation machine that you just can't show to anybody!
Kingfisher........I'm tired of the sizzle; I want some steak! You would think that if Dean went thru the bother of posting that he gained "great insight" from his conversation with the FDA reviewer that, shortly after, he would post what that insight was! A perfect example of hype and pump......pure BS!
The permabulls are all pinning their hopes on some positive news (re: 3D imaging) coming out of RSNA. Little do they know that they'll have to go to booth #7124 to get that.
Thanks Maddog. No, its not a big deal, but you would think that as long as they reserve a page on their website for "Press Releases" that, then they would.....oh, you know.....post their friggin press releases. Just a minor detail that seperates the men from the boys.
Why is this PR not posted on their web site? Another overlooked detail, or did Becky get her pink slip?
Tig........as long as you didn't mean that yesterday's hammer with subsequent up-day confirms the end of the downtrend, we have no problem, because it doesn't. So long as the .25 high is not violated today, the downtrend will technically remain in tact.
Madtig........TA is so subjective! Yesterday's hammer marks a temporary low and today's action is simply the continuation of the reversion to the mean (the severely declining 20DMA). An uptrend will not be confirmed until .25 (the 11/09 high) is broken. Only then will you have a higher high and a higher low, the classic definition of an uptrend. GL
Next support for this POS is 7............chapter 7!
shaka.......their silence is deafening, isn't it?
Hmmmmmm......interesting, considering that the low for the day is .217!
Kimble......hence, contrary to your post #30217, we agree.
Kimble.....If Dean has a fresh FDA approval in his vest pocket, there will be activity at the booth for sure. But that's a HUGE if!
Wiz.......I agree. At this point, an RSNA appearance, lacking news, might do more damage (accentuating the negative) than good. On the other hand, the Radiological Devices Panel meets on Nov 17, and Dean might be betting that he will eke out an approval just prior to the show, and use the show to herald his triumph.
Boogie..........Is the General and Plastic Surgery Devices Panel the appropriate entity to be reviewing Cardium's 510K?
Valuable lesson learned......don't fight the tape!
madtig......thats over 12.25%.....very loose stop for a stock that (lacking news) is going nowhere but down. Good luck!
Bigbreak.........Do you love the ".28 hold" as much as you loved last week's the .30 hold?
Bigbreak......Accumulation is not defined by, and nor is it characterized as, "normal backing and filling". Before he used the word as frequently as you do, I would think a normally intelligent person would look it up to find out what it means.
If 311 days is the longest 510K review, then beyond Feb 15, 2011 for IMGG's submission breaks the record. Do I smell a new deadline?
Can anybody help? Why this disconnect between nat gas and crude?And, comming into winter, how long can it last? I don't have a clue.
Benny.........respectfully, all this talk about MM "manipulation" puts me to sleep. It's nothing more than a thinly veiled attempt to make HS smell like roses and vice versa. Price action tells all.
THANKS DAK.......very helpful.
Can anyone provide the date of I3's original submission and a chronoligical list of important events (clock stoppages, restarts, resubmissions, AI's, etc.) that have gotten us from then to where we are today? I'm having a hard time figuring out why this thing has taken 4- years (considering Dean has had four previous successful submissions) and we still seem to be SSATT. TIA.
TA is so subjective. .30 (even number support helped by the 50DMA) held on a closing basis yesterday for the first and only time since Monday's .33 violation. Today, the .30 level has become resistance. That fact, along with today's lower high and lower low makes the near future look very ominous.
The facts contained in vanbookie's post #28027 aint gonna help matters either. Couldn't happen at a worse time.
IMGGorBUST...................FYI.
Please review the following excerpts taken from the below linked publications ( I have highlighted portions that are pertinent to our previous discussion concerning 510K approval routing and authorization):
1. Division Acceptance and Review
http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/ucm070201.htm
After the 510(k) is logged in by the Document Mail Center, the 510(k) is sent to the appropriate ODE or OIVD reviewing division for the type of device. Delivery to the proper reviewing division will be facilitated by completing information on the Cover Sheet and Cover Letter, such as, advisory panel, Code of Federal Regulations reference, and product code.
2. Radiology Devices Move To OIVD
http://www.medicaldevicestoday.com/2010/02/radiology-devices-move-to-oivd-more-cohesive-dx-reviews-ahead-.html
FDA hopes that shuttling its Radiological Devices Branch to the Office of In Vitro Diagnostic Device Evaluation and Safety will produce more cohesive policies on diagnostic device review.Issues under the jurisdiction of the radiological branch, which regulates diagnostic imaging equipment as well as other radiation-emitting devices, have been a source of high-profile tensions within the Office of Device Evaluation, but the agency says the move responds to long-term discrepancies between how in vitro and in vivo diagnostics have been regulated by FDA.FDA Commissioner Margaret Hamburg signed the orders in January that officially moved the review branch from its current home in ODE to a new spot in OIVD (The Gray Sheet' Jan. 25, 2010)."We found that we were drifting somewhat in how OIVD was regulating diagnostics and how some of the ODE was doing some of their diagnostics," explained OIVD Director Alberto Gutierrez.OIVD will now house four product divisions - the division of chemistry and toxicology devices; immunology and hematology devices; microbiology devices; and, now, radiological devices.The center originally tried to deal with the disparities by maintaining a core group of statisticians that worked with both offices, he said."They kind of acted as a go-between," he explained, but "that just didn't seem to be doing the job as well as we would like.
In summary, the reviewing division for the I3 application is the Division of Radiological Devices within the OIVD and, according to the above linked FDA document, the application was sent to that division from the mail center for review.
3. Decision Letter Issued
The decision letter will be mailed and faxed, if a fax number has been provided, to the submitter upon receipt of the completed 510(k) from the reviewing division.
Thus, the reviewing division of the I3 application, the Division of Radiological Devices, will forward the decision letter to the mail center for sending or faxing to I3.
Now, the question is who actually will make the final decision.
4. I refer you the 5:54 minute mark of the video " View the 510(k) Process Video" contained in the above FDA link, where it is stated:
"After the reviewing division completes the scientific review and corresponding documentation, a decision letter is forwarded through supervisory channels to the division director. If he or she agrees with the determination, the letter is signed, logged out of the division, and brought to the document mail center for dating and final processing."
Thus, it is the director of the Division of Radiological Devices, within the OIVD, who is responsible for making the final decision.
Finally, who is the director of the Division of Radiological Devices?
5. http://www.fda.gov/aboutfda/centersoffices/cdrh/cdrhoffices/ucm127854.htm
Division of Radiological Devices Donald St. Pierre* (acting) 301-796-5454
In conclusion, you will notice that nowhere in the aforereferenced publications are the names “CDRH” and “Jeff Shuren” mentioned as having anything to do with the 510K approval process.
*A telephone call to the office of the Division of Radiological Devices revealed that Donald St. Pierre has since been replaced by David Brown, Ph.D.
GL
3Run......many professional traders will tell you that they trade "naked"; that is without the use of any indicators or other ephemeral data whatsoever. Their mantra is that price action, and price action alone, tells the whole story, and injecting anything else only clouds the analysis. They even have written books on the subject. I suppose it's what each individual is comfortable with.
I personally have a hard time understanding why it matters to the markets whatsoever whether the people doing the selling own the shares they are selling or are simply borrowing them. Selling is selling, and it's simply one side of the supply/demand equation. But hey.....thats just me. GL.
Bigbreak.......critical support is at .33, and that level is holding on a closing basis. A break below that level on a closing basis IMO would spell trouble. The 50 DMA is supporting the intraday lows (for the time being) at or above .30.
Dragon.....thanks, but we all know what Dean said. The issue is whether the July 5 submission was in fact a response to a formal AI request, or whether the FDA views it in that light.
Shaka.....Assuming that you are correct and the July 5 "voluntary" submission was a reply to a formal AI, and given the fact that an AI only stops (not resets) the clock, then what date is the new deadline?