Holidays or some of us are just sitting back and hope for the best. We have a long way
to go but seeing this is very nice! Best of luck to all of us shareholders!
Yes this has been way over sold. I would think it is a good time to buy. But don't do it because I say it do what you think is right for you.
Could have gains on other stocks this year so he sold some here to show a loss?
I don't know, maybe he wants to buy a new car or house or just go on vacation.
Kania works for Flagship Ventures. Not BGMD, Even so Candy , Why sell them ??
What insiders? You mean insider. Kania, he was probably paid in stock instead of cash to help preserve cash until FDA approval.
It just doesn't make sense If they know the Submission is still active, Why sell ???
If it was for a tax write off it surely doesn't sense, If They would not take the write off and make 3 the the money if it were cleared.
This is beyond bizarre IMO I don't get it
No I dont know why the delay. Last I checked in with abbott was dec 2nd. They said nothing has changed and still in the hands of FDA. I think FDA needed more time. Maybe to review the new studies that Bgmd had released in NOV? Or they are just understaffed and need more time to go over the information. It's not uncommon. I saw that the last assay for the architect took 13 months. Submitted 2/01/13 and approved on 2/28/14. I will check back with them in January.
and subsequent to that Abbott came along and aboard and resubmitted new data and this is what we are currently awaiting, I am not concerned about what happened in 2012, all I am concerned with is the latest submission and I have seen nothing telling me FDA has rejected this....I still believe that Abbott being involved in this sponsorship, means alot.......I am sticking with my belief in this product and that soon the stock will jump mightily post FDA approval......again time will tell....GL and I enjoyed the respectable banter---
July 2012, we announced the filing of a 510(k) Premarket Notification with the U.S. Food and Drug Administration (FDA) for regulatory clearance for the Abbott ARCHITECT® galectin-3 assay, which is used with Abbott’s fully automated ARCHITECT® immunochemistry instrument platform. In August 2012, Abbott received a letter from the FDA regarding its 510(k) notification that requested additional information and Abbott is undertaking activities to respond to the FDA. In addition, we expect that, in late 2012 or early 2013, Abbott will begin marketing an automated version of the test in the EU under a CE Mark. In May 2012, we submitted a 510(k) to extend the labeling indication for the BGM Galectin-3 test to include individuals in the general adult population who are at risk for developing heart failure based on elevated levels of galectin-3. In July 2012, we received a letter from the FDA regarding our 510(k) notification that requested additional information, including information regarding our clinical validation study and additional analytical study data, and we submitted our response to the FDA in November 2012. If we obtain clearance in the United States for this additional indication, we expect that the potential market for the BGM Galectin-3 test will increase significantly. In May 2012, we also obtained CE Mark in the EU for this expanded indication for the BGM Galectin-3 test.
That may be J, But if you do a little DD, you see the first Automated gal 3 test was kicked back about a month after it was submitted and it wasn't made public till Nov 2012, go look at the filing
not true Lil.....FDA rejects applications/requests all the time, I recall listening to an FDA conference call regarding ARNA a few years back and the pending request was going to be formally approved or denied...that particular vote was favorable to ARNA but had it been denied it would have been announced immediately.....I have also seen rejections from FDA regularly over the years that were announced by FDA not the company in question.
Hi J, The FDA Will Only post a clearance, If it does not get cleared , Its up to the company to inform investors, When they didnt get cleared in the last filing , the company released that news in Nov of that year , but they had that info in july.
This is just my opinion, But the buyer of shares in april of this year could have very well shorted the Stock to bring it where it is now, they knew it would take many many months , and if they had to cover they had the 6m shares they bought in april, NOT A BAD GAME HUH !!!
as for taking a long time, the fda cleared version og gal 3 test took 11 months and 10 days to get cleared
this stock is priced as though the FDA is not going to approve-----yet, that is not the case, we have not seen nor heard a decision from the FDA.......so my question is why has it come down so much to the point where market cap is $10mil or so........
When FDA makes their decision on something, they announce it immediately-----they cant play games with the announcements, etc etc.....so IMO how could anyone say a decision on this has been made? FDA does not leak info and they know the law /SEC regs etc as well as anyone......that is what is bewildering to me.......
Exactly what has happened to bring it down like it has gone ? Other than a time frame lasting much longer for the decision to be made, I dont see anything that should be punishing the stock like it has? Perhaps it wont get FDA approval, most still think with Abbott on board and background on the test, it should get approved.....I think what has caused the decline is lack of patience from retail owners, so for now I still think this stock has life, sure am not selling here.....they cant come get my dog can they? I still am keeping faith and still think it is a good risk/reward esp at this crazy low level.......time will tell, GLTA