Wouldn't it be nice to see BGMD's pps rise as a result of pure interest in the overall
Healthcare Market alone?
Sentiment: Strong Buy
( Should hear something within 6 weeks )
6Weeks ???? To be honest , We should have heard something 6 weeks ago, This is a follow up 510K filing that the FDA requested more information, As for substantial equivalence determination, We should have passed that with flying colors, Dont know what the hold up here is, But it seems to be taking a little to long for a follow up filing.
If we filed in the middle of Feb. that would be 156 days, Makes me think that the FDA ( MAY ) have requested more information AGAIN, Hope im wrong.
(The FDA sets internal goals to review and respond to 510(k) submissions within 90 days.
However, that’s a little misleading when taken at face value. When you submit a 510(k) submission to the FDA, the clock starts. However, when they come back to you with an Additional Information (AI)” request, they stop the clock. The FDA does not count the days when they are waiting on you to provide the additional information they need to determine Substantial Equivalence.
Therefore, many people think they have a good chance of getting their 510(k) cleared within 90 days but the reality is that only 28% of 510(k) submissions cleared in 2013 were done within 3 months. So, the 90 day goal set by the FDA should largely be ignored when you are trying to determine how long it will actually take to get your 510(k) reviewed and cleared.
On average, it takes 166 days for the FDA to review and clear a medical device 510(k) application.
Back in 2006, it only took 110 days for the FDA to clear a 510(k) application. But from 2006 to 2011, review times gradually lengthened, topping out at 176 calendar days in 2011. The average number of days, it should be noted, is calculated in calendar days from the time the FDA receives a 510(k) submission to the time it is cleared. The good news is that in the last few years the time needed to get a device through the FDA process has stabilized, as you can see below.
Hence, we see the 2.00 range over the next three weeks then some diution and back to 1.50 long term this is a 10 dollar stock
NASDAQ shows 31 institutional holders (17.6% - 6,056,774) and 4 insiders.
The "33" number cannot be correct.
As of June 30, 2014, there were approximately 33 stockholders of record of the 34,417,249 outstanding shares of our common stock.
You mean to tell me theres only 33 of us Idiots !!!!!!
The Abbott Architect automated Galectin-3 immunoassay has been in use in Europe for over a year now. The current BGMD Galectine is already FDA cleared. Several studies have shown automated version just as effective as current BGMD Galectine. This should be easy for FDA. It is not like it is a totally new immunoassay with nothing to compare it to. Should hear something within 6 weeks a latest. IMHO
Another nice find
Sentiment: Strong Buy
Same filing last year. Nothing new.
BG MEDICINE, INC.
4,106,071 Shares of Common Stock
This Prospectus Supplement No. 3 supplements and amends the prospectus dated June 7, 2013 relating to the sale of up to 4,106,071 shares of our common stock by Aspire Capital Fund, LLC, or Aspire Capital.
This prospectus supplement should be read in conjunction with the prospectus dated June 7, 2013, as well as Prospectus Supplement No. 1 dated August 14, 2013 and Prospectus Supplement No. 2 dated August 14, 2013, which are to be delivered with this prospectus supplement. This prospectus supplement is not complete without, and may not be delivered or utilized except in connection with, the prospectus, including any amendments or supplements to it. We will not receive any proceeds from the sale of the shares of common stock by Aspire Capital.
Funny how this test was done with ((( Galectin-3 was measured with an Abbott Architect automated immunoassay. )))
Abstract Background: Galectin-3 is an emerging biomarker of heart failure and of myocardial fibrosis risk. Monitoring of galectin-3 is essential during treatment with galectin-3 inhibitors. The aim of our study was to assess long-term biological variability in a specific group of unhealthy subjects. Methods: The biological variability of galectin-3 was measured in a group of 44 patients after heart transplantation (HTx). Six samples were taken from each patient during a 12-month period. Galectin-3 was measured with an Abbott Architect automated immunoassay. Results: Intraindividual (CVi) and interindividual (CVg) variabilities were calculated together with the reference change value (RCV), the log-normal RCV for increase (RCV+), and the log-normal RCV for decrease (RCV-). The CVi, CVg, RCV, RCV+, and RCV- were 28.2%, 35.6%, 78.6%, 116%, and -53.7%, respectively. The index of individuality was 0.79. Conclusions: The concentrations of galectin-3 in patients followed 12 months after HTx fluctuated around the homeostatic point, with CVi of approximately 28%. RCVs of +116% (log-normal increase) and -54% (log-normal decrease) mean that the concentration of galectin-3 would need to approximately double or decrease by half to indicate a new process.
Hal does not worry about the stock, when the fact come out we will know and we are a growing company with a product that is and will be in demand. IMO BGMD will pull the trigger on the 41millionat the highest price point. I am adding while these prices are low - call me risky or greety...
I agree. These guys know what they are doing. The higher the price the more money they can raise. On the lasy CC they also said they would have sales force doubled by end of 2nd quarter, also. Coincidence?? They like to issue more shares on pops.
Funny how all of this is coming together just as Abbott Automated Galectin 3 Assay is coming due, And Earnings are due out Aug. 13, Est ( 06 ) before market opens From earnings whisper,
Do you know if a "Poison-Pill" shareholder plan was introduced in the past by the BOD.??
This trading behavior along with the appearance of a delayed tactic is begining to be more apparent of
a delayed tactic. So it appears. Just my IMHO.
We never know what really goes on behind close doors.