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Acusphere, Inc. Announces Receipt of NASDAQ Panel Decision to Delist Common Stock
http://finance.yahoo.com/news/Acusphere-Inc-Announces-bw-13996322.html
Press Release Source: Acusphere, Inc.
Acusphere, Inc. Announces Receipt of NASDAQ Panel Decision to Delist Common Stock
Wednesday January 7, 2009, 4:54 pm EST
Yahoo! Buzz Print Related:Acusphere Inc.
WATERTOWN, Mass.--(BUSINESS WIRE)--Acusphere, Inc. (NASDAQ:ACUS - News) announced today that it has received notification that the NASDAQ Listing Qualifications Panel has determined to delist the Company’s common stock from The NASDAQ Stock Market, effective with the open of business on Friday, January 9, 2009. The delisting is the result of the Company’s failure to meet the $2.5 million stockholders’ equity requirement for continued listing on The NASDAQ Capital Market or one of the alternative continued listing criteria.
Acusphere expects that its common stock will be eligible for trading on the Over-the-Counter Bulletin Board (the “OTCBB”), an electronic quotation service maintained by the Financial Industry Regulatory Authority (FINRA), effective with the open of business on Friday, January 9, 2009. The Company’s shares are expected to continue to trade under the symbol ACUS.
About the OTCBB
The OTCBB is a regulated quotation service that displays real-time quotes, last-sale prices, and volume information in over-the-counter equity securities. An over-the-counter equity security generally is any equity that is not listed or traded on a national securities exchange. OTCBB securities include national, regional, and foreign equity issues, warrants, units, ADRs, and Direct Participation Programs. More information is available at http://www.otcbb.com.
About Acusphere, Inc.
Acusphere (NASDAQ: ACUS - News) is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology. We are focused on developing proprietary drugs that can offer significant benefits such as improved safety and efficacy, increased patient compliance, greater ease of use, expanded indications or reduced cost. Our lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, is a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States, for which a New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) in April 2008 and filed in June 2008. Imagify is designed to enable ultrasound to compete more effectively with nuclear stress testing, the leading procedure for detecting coronary artery disease. It is estimated that more than 10 million procedures are done each year in the U.S. to detect coronary artery disease, the leading cause of death in the United States. The Company estimates that the potential annual U.S. market opportunity for Imagify exceeds $2 billion. Imagify and the Company's other product candidates were created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microspheres in a versatile manner that allows them to be customized to address the delivery needs of a variety of drugs. For more information about Acusphere visit the Company's web site at http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.acusphere.com&esheet=5866197&lan=en_US&anchor=www.acusphere.com&index=2.
"Acusphere" and "Imagify" are trademarks of Acusphere, Inc.
The above press release contains forward-looking statements, which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, including statements regarding the development and commercial opportunity for Imagify. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including anticipated operating losses and existing capital obligations, uncertainties associated with research, development, testing and related regulatory approvals, including uncertainties regarding regulatory evaluation of the Company's statistical analysis plan and clinical trial results and uncertainties regarding the potential effects of not achieving clinical endpoints, limited time to date for the Company to review the details of the clinical trial results, future capital needs and uncertainty of additional financing, uncertainties regarding the cost, timing and ultimate success of the qualification of the Company's commercial manufacturing facility in accordance with applicable regulatory requirements, complex manufacturing, high quality requirements, lack of commercial manufacturing experience, dependence on third-party manufacturers, suppliers and collaborators, uncertainties associated with intellectual property, competition, loss of key personnel, uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation, a trading market may not develop for our common stock on the OTCBB and other risks and challenges detailed in the Company's filings with the U.S. Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2007 and the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2008. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this press release or to reflect the occurrence of unanticipated events.
Contact:
Acusphere, Inc.
Lawrence A. Gyenes, 617-648-8800
Chief Financial Officer
or
Investors:
617-925-3444
IR@acusphere.com
Form 8-K/A for ACUSPHERE INC
http://biz.yahoo.com/e/090107/acus8-k_a.html
--------------------------------------------------------------------------------
7-Jan-2009
Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Exhibit
10.1* Note Purchase Agreement by and between Acusphere, Inc. and
Cephalon, Inc. dated as of October 24, 2008 (incorporated by reference
to Exhibit 10.1 to the Company's Current Report on Form 8-K/A filed
with the Commission on October 31, 2008)
10.2* Form of Senior Convertible Note of Acusphere, Inc. issued to
Cephalon, Inc. (incorporated by reference to Exhibit 10.2 to the
Company's Current Report on Form 8-K filed with the Commission on
October 27, 2008).
10.3* Form of Pledge and Security Agreement by and between Acusphere, Inc.
and Cephalon, Inc. (incorporated by reference to Exhibit 10.3 to the
Company's Current Report on Form 8-K filed with the Commission on
October 27, 2008).
10.4* Form of Registration Rights Agreement by and between Acusphere, Inc.
and Cephalon, Inc. (incorporated by reference to Exhibit 10.4 to the
Company's Current Report on Form 8-K filed with the Commission on
October 27, 2008).
10.5 Form of License Agreement by and between Acusphere, Inc. and
Cephalon, Inc. (filed herewith).
99.1* Press Release dated October 24, 2008 (incorporated by reference to
Exhibit 99.1 to the Company's Current Report on Form 8-K filed with the
Commission on October 27, 2008).
Acusphere, Inc. Announces Resignation of Richard Walovitch
http://finance.yahoo.com/news/Acusphere-Inc-Announces-bw-13995329.html
Press Release Source: Acusphere, Inc.
Acusphere, Inc. Announces Resignation of Richard Walovitch
Wednesday January 7, 2009, 4:08 pm EST
Yahoo! Buzz Print Related:Acusphere Inc.
WATERTOWN, Mass.--(BUSINESS WIRE)--Acusphere, Inc. (NASDAQ: ACUS - News) today announced that Dr. Richard Walovitch, Senior Vice President of Clinical Research, has resigned to pursue another opportunity. His resignation, effective January 9, 2009, follows an 11 year career with Acusphere, in which he oversaw the Company’s clinical trials for its lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, a cardiovascular drug for the detection of coronary artery disease, which addresses a potential $2 billion U.S. marketplace.
Said Dr. Walovitch, “I am very proud to have been associated with Acusphere’s efforts on behalf of Imagify, and our work to demonstrate its benefits to patients and physicians. As the Company awaits completion of the review by the U.S. Food and Drug Administration, now is the right time for me to move to the next phase of my career, and I’m grateful for the experience of working with my many talented colleagues at Acusphere.”
Sherri C. Oberg, President and CEO of Acusphere, said, “Rick has made many significant contributions to Acusphere’s success over the past 11 years, and we greatly appreciate his commitment to seeing this project through to its final stage. We wish him well in his next venture.”
About Acusphere, Inc.
Acusphere (NASDAQ: ACUS - News) is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology. We are focused on developing proprietary drugs that can offer significant benefits such as improved safety and efficacy, increased patient compliance, greater ease of use, expanded indications or reduced cost. Our lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, is a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States, for which a New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) in April 2008 and filed in June 2008. Imagify is designed to enable ultrasound to compete more effectively with nuclear stress testing, the leading procedure for detecting coronary artery disease. It is estimated that more than 10 million procedures are done each year in the U.S. to detect coronary artery disease, the leading cause of death in the United States. The Company estimates that the potential annual U.S. market opportunity for Imagify exceeds $2 billion. Imagify and the Company's other product candidates were created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microspheres in a versatile manner that allows them to be customized to address the delivery needs of a variety of drugs. For more information about Acusphere visit the Company's web site at http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.acusphere.com&esheet=5866116&lan=en_US&anchor=www.acusphere.com&index=1.
"Acusphere" and "Imagify" are trademarks of Acusphere, Inc.
Forward-looking Statements
The above press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, including statements regarding, the NDA submission for Imagify and likelihood of regulatory approval and the commercial opportunity for Imagify. There can be no assurance that Imagify will be approved for the indication the Company is seeking, or at all. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including anticipated operating losses and existing capital obligations, uncertainties associated with research, development, testing and related regulatory approvals, including uncertainties regarding regulatory evaluation of the Company's statistical analysis plan and clinical trial results and uncertainties regarding the potential effects of not achieving clinical endpoints, limited time to date for the Company to review the details of the clinical trial results, future capital needs and uncertainty of additional financing, uncertainties regarding the cost, timing and ultimate success of the qualification of the Company's commercial manufacturing facility in accordance with applicable regulatory requirements, complex manufacturing, high quality requirements, lack of commercial manufacturing experience, dependence on third-party manufacturers, suppliers and collaborators, uncertainties associated with intellectual property, competition, loss of key personnel, uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation, and other risks and challenges detailed in the Company's filings with the U.S. Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2007 and its Form 10-Q for the quarter ended September 30, 2008. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this press release or to reflect the occurrence of unanticipated events.
Contact:
Acusphere, Inc.
Lawrence A. Gyenes, 617-648-8800
Chief Financial Officer
or
Investors, 617-925-3444
IR@acusphere.com
Hello Dew,
Have you ever run it with a laptop cooler?
Targus makes one sold at most office depot type stores, and there are many knock offs on line.
1, 2, or 3 fans on the coolers suck heat away from the laptop and out the top of the cooler.
We run them on all of our laptops around here, and gave them as Christmas presents this year to some family who didn't have them.
We run Pc compat. laptops and you need a USB port to plug them into, and I don't know if Macs have those or not, but if they do, that's all the coolers need to operate.
just found this mac one at bestbuy.com:
http://www.bestbuy.com/site/olspage.jsp?skuId=9041547&st=laptop+cooler&lp=6&type=product&cp=1&id=1218013136549
Take Care.
<<(a) For purposes hereof, Cephalon may be deemed to be the beneficial owner of the 69,283,733 shares of Common Stock, representing 58.3% of the outstanding Common Stock,>>
This is the quote out of that link you posted, thanks for that. (link back to see it.)
Funny, but I listened to the conference call and I could swear they used 51% in that call, and then confirmed it in a q and a session at the end of the call. I have read others that used the 51% as well.....???
GFP has posted here before that it would be close to 53%, and I have found his diggings to be really well thought out in the past. Well, 51%, 53%, or 58%, it's all pretty close, as CEPH would have control.
The deal they inked was complex, at least for me to grasp.
They have a year, I believe from the signing, to execute any of the options.
I would love to see something put out that CEPH is buying on the open market as I would take it as a sign they would want to grab up the rest of the outstanding shares.
Take Care and GLTU.
Not True <<<ACUS is 58% owned by CEPH>>
Hello RonnieD,
Ceph does not own 58% of ACUS.
In fact I don't think there are any current SEC documents that show CEPH with even 5% of ACUS at this point, at least I don't remember seeing any.
Ceph did enter an agreement recently, wherein they can end up with approx. 51% of ACUS, if they exercise certain conditions. They have not, as yet, committed to any of the three options they have under that agreement.
They have 3 choices to choose from, all written about rather extensively here in previous posts, or just search yahoo news stories on ACUS and scroll back a month or two.
Just wanted new investors to be aware.
That said, CEPH did like ACUS enough to put up 20 million into ACUS coffers, just weeks before the FDA advisory panel meeting.
To date the 2/28/09 FDA PDUFA date is still intact, but I would think that may change, depending on the events that unfold between now and then.
Take Care.
Form 8-K for ACUSPHERE INC
http://biz.yahoo.com/e/081218/acus8-k.html
Form 8-K for ACUSPHERE INC
--------------------------------------------------------------------------------
18-Dec-2008
Change in Directors or Principal Officers, Financial Statements and Exhibits
Item 5.02 Departure of Directors or Certain Officers; Election of
Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On December 12, 2008, the Board of Directors (the "Board") of Acusphere, Inc. (the "Company") decided that no amounts that would have been payable under the Company's fiscal year 2008 Management Incentive Plan, as described in the Company's proxy statement filed with the Securities and Exchange Commission (the "Commission") on April 28, 2008, will be paid to any members of the Company's management committee (the "Executives"). However, given the importance of retaining the Executives in order to manage the regulatory and financial uncertainties faced by the Company, the Board has approved the additional measures described herein to strengthen the retention of the Company's Executives.
On December 12, 2008, the Board approved, effective December 16, 2008, a change in the base salaries of the Executives, including the named executive officers listed below, such that their base salaries would return to the amount in effect immediately prior to the reduction taken pursuant to the Company's Senior Management Compensation Plan (the "Compensation Plan"), disclosed by the Company in the Current Report on Form 8-K filed with the Commission on July 28, 2008. The base salaries in effect as of December 16, 2008 are set forth below:
Base Salary
effective
December 16,
Name Position Current Salary 2008
President and Chief Executive
Sherri C. Oberg Officer $ 371,128 $ 463,910
Senior Vice President and Chief
Lawrence A. Gyenes Financial Officer $ 292,500 $ 325,000
Senior Vice President, Clinical
Richard Walovitch Research $ 252,000 $ 280,000
Senior Vice President, Regulatory
Michael Slater Affairs and Operations $ 232,000 $ 290,000
In addition, the Board determined that, prior to December 31, 2008, the Company would pay Ms. Oberg and Mr. Slater each a lump sum equal to half of the base salary reduction taken in connection with the Compensation Plan. As a result, Ms. Oberg and Mr. Slater will receive a lump sum payment of approximately $17,397 and $10,320, respectively.
On December 12, 2008, the Board also adopted an Executive Retention Bonus Plan (the "Retention Bonus Plan"), which provides that each Executive, including the named executive officers listed below, shall receive a retention bonus equal to one-third of their base salary in effect as of December 12, 2008, before taking into account the reduction provided for in the Compensation Plan (the "Retention Bonus"). The Company will pay the Retention Bonus in lieu of cash payments otherwise potentially payable under the Compensation Plan, if (a) such Executive remains employed by the Company through the date that is fifteen days after the Prescription Drug User Fee Act ("PDUFA") date for Imagify� (Perflubutane Polymer Microspheres for Injectable Suspension), currently expected to be February 28, 2009 (the "Payment Date") or (b) such Executive is terminated by the Company as a result of the termination of their position prior to the Payment Date, as set forth below:
Retention
Name Position Bonus
Sherri C. Oberg President and Chief Executive Officer $ 154,637
Senior Vice President and Chief
Lawrence A. Gyenes Financial Officer $ 108,333
Richard Walovitch Senior Vice President, Clinical Research $ 93,333
Senior Vice President, Regulatory
Michael Slater Affairs and Operations $ 96,667
--------------------------------------------------------------------------------
If the Company terminates the Executive for Cause (as defined in the Retention Bonus Plan), or for any other reason other than a termination of the Executive's position, or if the Executive resigns his or her employment with the Company prior to the Payment Date, he or she shall not be entitled to any Retention Bonus. In addition, to the extent the Executive receives severance payments under the Executive Employment Agreement between the Executive and the Company as a result of termination of employment prior to the Payment Date, the Executive will not be eligible for payment under the Retention Bonus Plan in connection with such termination of employment.
The above summary of the Retention Bonus Plan does not purport to be complete and is qualified in its entirety by reference to the Retention Bonus Plan, a copy of which has been filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated into this Item 5.02 by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
No. Description
10.1 Executive Retention Bonus Plan
Housekeeping Note,
Just a note to please try and keep the posts here on-topic about Acusphere DD as much as possible.
This is not a chat room and one line, or off topic, posts will be deleted going forward. I mentioned this last week, but did not headline the post, so it could have easily been missed.
I am all for traders making money here, so best of luck to all who got into ACUS recently, as well as those who rode out the recent FDA advisory panel meeting, and got crushed in the process.
Internet Explorer browser might be vulnerable to having their computers hijacked
---this just came out on the yahoo news main page.-----
http://tech.yahoo.com/news/ap/20081215/ap_on_hi_te/tec_internet_explorer_security
SAN FRANCISCO - Users of all current versions of Microsoft Corp.'s Internet Explorer browser might be vulnerable to having their computers hijacked because of a serious security hole in the software that had yet to be fixed Monday.
The flaw lets criminals commandeer victims' machines merely by tricking them into visiting Web sites tainted with malicious programming code. As many as 10,000 sites have been compromised since last week to exploit the browser flaw, according to antivirus software maker Trend Micro Inc.
The sites are mostly Chinese and have been serving up programs that steal passwords for computer games, which can be sold for money on the black market. However, the hole is such that it could be "adopted by more financially motivated criminals for more serious mayhem — that's a big fear right now," Paul Ferguson, a Trend Micro security researcher, said Monday.
"Zero-day" vulnerabilities like this are security holes that haven't been repaired by the software makers. They're a gold mine for criminals because users have few ways to fight off attacks.
The latest vulnerability is noteworthy because Internet Explorer is the default browser for most of the world's computers. Also, while Microsoft says it has detected attacks only against version 7 of Internet Explorer, which is the most widely used edition, the company warned that other versions are also potentially vulnerable.
Microsoft said it is investigating the flaw and is considering fixing it through an emergency software patch outside of its normal monthly updates, but declined further comment. The company is telling users to employ a series of complicated workarounds to minimize the threat.
Many security experts, meanwhile, are urging Internet Explorer users to use another browser until a patch is released.
___
On the Net:
Microsoft's advisory:
http://www.microsoft.com/technet/security/advisory/961051.mspx
Ahh, Thank You tc!
I had not been able to confirm that the spell checker would not jive with xp64 till I read your link.
I had researched the office bundle before purchasing it to make sure it would work with xp64, but found no mention of this issue. The rest of the bundle seems to work fine in xp64.
I really like xp64's speed compared to xp32. Oh Well.
Thanks again.
Good One. Well, after 4 hours and 4-5 system restores, I now have an English dictionary listed in outlook express, but I still get the exact same msg I got when I first decided I wanted to fix this issue:
"An error occurred while the spelling was being checked."
Then nothing. It now shows the english version, and a few other dictionary options I loaded from an old copy of Office 2000 premium.
It used to just show a French dictionary, and that is the issue with Office 2007 and Outlook Express 6.
There are now 4 or 5 choices in the drop down menu and I have tried them all with no success, same error msg.
This fix is posted all over the internet, so I either loaded them wrong, or XP64 is causing some unknown error.
The office 2000 english dictionary works fine in Word 2007, just not outlook express.
Do you think microsoft would not fix this because they want us to upgrade to Vista? No, a big US company, would never treat their loyal, 20 year, customers like this would they?
Their site is pathetic, they point you to blogs for a fix to this well known problem, rather then issue a patch.
I am open to suggestions????
Thanks.
Humm, Now since I can barely spell english, I think the French people would prefer I fix my computer!
Susie, the program you suggested did not work with xp64, thanks for trying!, neither did another i tried from microsofts web site, so i am going to try this next:
found of microsofts web site:
Fixed my dictionary. Here's how I did it. I used my Office XP install disc
and ran it as if to reinstall the older Office then "X'd" everything except
"Office Shared Features" / "Proofing Tools" / "English". (I tested my
dictionary by typing this as a e-mail message then copy/pasted)
Setup.exe
Add or Remove features (or) Custom Install
Check "Not Available" on everything except "Office Shared Features"
Under Shared Features check Not Available on everything except "Proofing
Tools"
Under Proofing Tools check French and Spanish as Not Available. Then check
English as "Run All From My Computer"
Continue with the rest of the Install / Repair
"Radios" wrote:
Click to show or hide original message or reply text.
> OK: I'll get this posting stuff. For what it's worth, my dictionary changed
> to French after installing Office Enterprise 2007. I'm just starting to
> repair my dictionary today.
>
> "Mocsab" wrote:
>
> > The dictionary in my OUTLOOK EXPRESS is FRENCH and I cannot find a way to
> > install or change it to ENGLISH. (I also don't know why there is French
> > Dictionary installed in the first place - it is not something I did)
> >
> > How and where can I download and install an ENGLISH DICTIONARY for OUTLOOK
> > EXPRESS? I have tried re-installing IE 7 - but it has not changed the
> > Dictionary - I appreciate any help anyone can offer -
Thanks Grinch52, When I go to Word options, I have english as my chosen editing language.
I finally found in Word where my custom dictionary list is set to US English.
My guess is that outlook is pointing to a custom.dic file that is empty, rather than the one that office word is using in one of its subdirectories????
////UProff
Any ideas on how to repoint that file, or maybe I can copy it to the one outlook is looking at. Both are called Custom.dic.
Thanks Susie924, When I go there, I get only the French language as an option in the drop down list.
When I click on edit custom dictionary, I get a notepad file opened that is called custom.dic, and is empty?????
Thanks.
I am stumped!
I am running a fully patched Windows XP64 machine and I run outlook express as my email program.
I am not networked on this machine.
I also have Microsoft Office for Student/Home installed.
When I go to check spelling in an email, I get, "An error occurred while the spelling was being checked."
When I go to outlook expresses tools/options/spelling tab, I see that for some reason, I have a french dictionary installed????
The "Edit Custom Dictionary" button only gives me the French option, no English option is there.
All software is legal, I bought the Office bundle at Best Buy, it is registered with Microsoft and I have it fully patched. It is an english version, I didn't even know it had French??????
When I run Microsoft Word, and I check spelling, it uses an english dictionary, as it seems to work fine and gives me english options on spelling corrections.
I am an AWFUL speller! I couldn't even spell "occurred" in this post without checking the actual error msg I am getting, as my guesses on how to spell, "occurred" were all incorrect while using I-Hubs spell checker, Pathetic, I know
Any Help Is Appreciated!
Thanks in advance.
"What about what tc suggested?"
I tend to agree that it is hardware related, because that is my experience, so I guess it could absolutely be a keyboard or mouse, just never happened to me before, other than a keyboard with a key getting stuck down.
"Right now I can't really back anything up because I can't type in the file name when i go to back up "
Now THAT sounds like swapping a keyboard/mouse would be my first try! Just borrowing one from someone is a no cost test.
Make sure you power off your machine completely before swapping them, unless you have a current USB keyboard/mouse, being replaced by a usb keyboard/mouse.
If it is not the keyboard/mouse then my guess is you are in for a frustrating experience. Power supplies were always my hardest to diagnose. Not trying to be negative, just trying to prepare, in case it goes that way.
Others may have great/simple ideas that I am missing.
GLTU
Hello cintrix, You are smart to try and back up if you can get back on.
Next time you see that msg, please write it down as there are folks on here that it might help to diagnose your issue.
I have had issues with frozen screens over the years that were memory related, motherboard related, and power supply related. None of those were good news and took some messing with to get straight. Those parts are much cheaper today then in years past, so that is some good news.
I would also make sure your fans are spinning correctly to make sure that whatever is failing is not heat related. The fact you were able to get back on before it froze again may be that a part is heating up. Just a WAG.
GLTU
Hello tonyvanw, I kept mine as well.
I wonder how long Sherri can keep all those 70+ employees on the payroll? I don't know the ratio of them that are required for the manufacturing facility, but there must be quite a few.
She may be letting Ceph and Nycomed know that if they have interest in the facility, she will have to pull the trigger on them soon to conserve cash. Her position may be, if they want to keep from a serious brain drain, then they better pony up sooner, or lose that window. I guess feedback from the FDA would need to come first but time is of the essence.
I was somewhat surprised in this mornings call when she stuck to her guns that she thought Imagify would stay on course for the same indication. I thought she might try to position it for a little less stringent indication given the 16-1 vote.
Take Care.
Thanks for the article atheroprevent,
"Their vote wasn't on the typical question of whether AI-700 was "approvable" but on the more exploratory question of whether the agent, used for rest/stress echocardiographic testing, is diagnostically effective enough to justify its associated risks."
Humm, 11 of 911 people showed AE's, (adverse effects) that the company considered of a serious nature. No one died. Most were a skin tone change or a drop in blood pressure. Many have died with the two approved agents out there, neither for cardio, one owned by GE. (can you say nuke?)
I once passed out at the red cross donating blood. I can assure you my blood pressure dropped.
I have also had radioactive dye put in me at the Mayo Clinic, and I felt like I had a fire lit inside my viens.
These folks would be getting these tests in a doctors office where the company felt like they would be easily treatable. They were not bringing something before the panel that patients were going to take before bedtime, or before they drove a car, completely unsupervised. They were in fact, by default, in an environment that could take care of those cases that did arise.
The board moved the end zone on ACUS. They compared Imagify to non dosed echo that was never in a trial design. The trial designs were put together with FDA input. It was never brought up that Acusphere should compare Imagify to non dosed echo.
I mean how can ANY COMPANY test for every possible idea that pops into a panelists head at the last minute. Simple, they can't. So throw enough doubt on what might have been, or if only's, and poof, there goes the target. Once the FDA statistician took control of the room, it was over. Then toss in one of the head Nuke guys, and they were buried. Funny, but Acusphere had one of the top Nuke men in the country help them with the trial design.
ACUS spent 370 MILLION dollars getting to that meeting.
I was reading posts from folks that were in the meeting and as the day wore on, I went to the movies because I could see that once the Radioligist's, with a VESTED interest in the Status Quo, took control of the meeting, it was going to be a negative vote for Imagify.
Ahh, but I vent, been building for 28 hours.
Good to see you over here and thanks again.
OT- I also enjoyed reading your COR post this afternoon on the hostile environment for drug development. Saved it.
Post Advisory Committee Conference Call
Dec 11, 2008 at 8:30 AM ET
http://investor.acusphere.com/
GLTU keithhpkns, I appreciated you keeping this board up.
I was granted current moderator, as I asked to be put on, as long as I am still in acus.
I would ask posters to please try and keep their posts about acus as much as possible. Posts should add something to the discussion of Acusphere.
I understand traders want to make a buck in it, but 1 line posts that add nothing will be deleted going forward.
To the poster asking about the conference call this morning, I did listen in. My read on it was that Sherri is hoping that Ceph or Nycomed will come to the rescue, as the private market has all but dried up for bios right now. It actually was an interesting call with respect to the current state of affairs at the FDA, and I will post the web address if anyone is interested.
Take Care keithhpkns.
Acusphere Announces Results of FDA Advisory Committee Meeting
Press Release Source: Acusphere, Inc.
http://biz.yahoo.com/bw/081210/20081210006231.html?.v=1
Acusphere Announces Results of FDA Advisory Committee Meeting
Wednesday December 10, 8:00 pm ET
WATERTOWN, Mass.--(BUSINESS WIRE)--Acusphere, Inc. (NASDAQ: ACUS - News) today announced that the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration advised that the diagnostic benefit of contrast enhancement using Acusphere’s ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension is not sufficient to justify the risks associated with the product. The vote was sixteen against, one in favor and one abstention. The Committee also discussed concerns that they would like addressed to support approval of the product for the detection of coronary artery disease.
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“We appreciate the support Imagify has received from a wide variety of cardiologists, who are eager for FDA to enable them to use the drug in their practices to improve accessibility, reduce costs and avoid exposure to radiation,” said Sherri C. Oberg, President and CEO, Acusphere. “We continue to believe in Imagify for its intended purpose and will work with FDA through the completion of the review process to determine what additional information might be required for approval.”
The Advisory Committee’s recommendations, while not binding, will be considered by the FDA in its review of the New Drug Application (NDA) of Imagify. The expected FDA target action date for Imagify under the Prescription Drug User Fee Act (PDUFA) is February 28, 2009.
Conference Call
Acusphere plans to hold a conference call with investors tomorrow, Thursday, December 11, 2008, commencing at 8:30 am (Eastern Time). The conference call will cover the Advisory Committee meeting, and will be led by Sherri C. Oberg, President and Chief Executive Officer and Lawrence A. Gyenes, Senior Vice President and Chief Financial Officer. These Acusphere representatives will also be available for investor questions. The conference may be heard live via the investor relations section of the Company's website at www.acusphere.com or by dialing 1-800-299-7635, or internationally 1-617-786-2901 using the confirmation code: 52594832. After the conference call, a replay of the call webcast will be made available via the Company's web site and a telephone replay will be available through January 11, 2009, by dialing 1-888-286-8010, or internationally 1-617-801-6888, using the confirmation code: 50372331.
About ImagifyTM
ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, is an investigational new drug developed to assess perfusion using ultrasound (or echocardiography) for the detection of coronary artery disease. Myocardial perfusion is blood flow in the heart muscle and is a sensitive marker of coronary artery disease. Currently, perfusion information is not available using cardiac ultrasound but must be obtained using a nuclear stress test, which is the most frequently used imaging procedure for detecting coronary artery disease. Imagify is designed to provide real-time perfusion information with quicker results, lower cost, broader access and no exposure to radiation compared with nuclear stress tests. Imagify was designed to be used with commercially available ultrasound equipment and established imaging techniques.
About Acusphere, Inc.
Acusphere (NASDAQ: ACUS - News) is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology. We are focused on developing proprietary drugs that can offer significant benefits such as improved safety and efficacy, increased patient compliance, greater ease of use, expanded indications or reduced cost. Our lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, is a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States, for which a New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) in April 2008 and filed in June 2008. Imagify is designed to enable ultrasound to compete more effectively with nuclear stress testing, the leading procedure for detecting coronary artery disease. It is estimated that more than 10 million procedures are done each year in the U.S. to detect coronary artery disease, the leading cause of death in the United States. The Company estimates that the potential annual U.S. market opportunity for Imagify exceeds $2 billion. Imagify and the Company's other product candidates were created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microspheres in a versatile manner that allows them to be customized to address the delivery needs of a variety of drugs. For more information about Acusphere visit the Company's web site at www.acusphere.com.
"Acusphere" and "Imagify" are trademarks of Acusphere, Inc.
The above press release contains forward-looking statements, which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, including statements regarding the development and commercial opportunity for Imagify. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including anticipated operating losses and existing capital obligations, uncertainties associated with research, development, testing and related regulatory approvals, including uncertainties regarding regulatory evaluation of the Company's statistical analysis plan and clinical trial results and uncertainties regarding the potential effects of not achieving clinical endpoints, limited time to date for the Company to review the details of the clinical trial results, future capital needs and uncertainty of additional financing, uncertainties regarding the cost, timing and ultimate success of the qualification of the Company's commercial manufacturing facility in accordance with applicable regulatory requirements, complex manufacturing, high quality requirements, lack of commercial manufacturing experience, dependence on third-party manufacturers, suppliers and collaborators, uncertainties associated with intellectual property, competition, loss of key personnel, uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation, and other risks and challenges detailed in the Company's filings with the U.S. Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2007 and the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2008. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this press release or to reflect the occurrence of unanticipated events.
Contact:
Acusphere, Inc.
Lawrence A. Gyenes, 617-648-8800
Chief Financial Officer
or
Investors, 617-925-3444
IR@acusphere.com
or
Media:
HealthStar Public Relations
Dave Schemelia, 609-468-9325
--------------------------------------------------------------------------------
Source: Acusphere, Inc.
Hello cintrix, I thought the triple play was phone/internet/tv.
We just got phone/internet for 69. The phone has unlimited long distance to USA, Canada, PR, and the Virgin Islands.
Verizon told me that all the parts are now installed if we decide to go to TV with them, but we are with DTV for a while longer.
At the end of the year we will need to sign up for a different bundle, or the verizon price goes to something like 42 internet, and 46 phone. We are thinking that they may have a great TV/phone/internet bundle by then.
The installers finished with us at around noon, and had 3 more installations they were going to try and finish today... busy.
Hope this helps.
Glad to hear you got out on Monday.
I still had hope that this group might send it to the pdufa date with a positive rec. Boy did I get fooled on that one.
Still the upside was enormous so I would likely have done the same thing again, if I could turn the clock back, based on the info I had, and the gut instinct I went with. It has served me well over the years, just not this time, so far.
Anyway best of luck to you with AMAG.
Ugg on this one for sure. 70+ employees up in Mass must be sick.
I was following a little today on the yahoo board as posters who were at the meeting, and some listening at home, were posting.
The saying cluster ____ comes to mind.
We are locking our shares up for now and will wait and see how much of the .42 or so share we can recoup down the road.
I thought the odds of getting past this group would be much better than in Feb., and the lopsidedness of the vote was rather staggering, to put it mildly.
I think with cash on hand and if they would sell their facility and liquidate everything, then maybe I break even
Will be an interesting conference call in the morning. It will be the mother of all positive spins. Glad I don't have to try and present it.
Take Care and brighter days ahead to you!
Hello Beachcomer1, We had Verizon Fios installed this morning at the house at the beach, and even though it is their slowest offering here at 10 download/2 upload, if FLIES. The installer told me they offer 50/50 service, but no clue on costs.
69/month gets unlimited phone/long distance/internet. Good for year. Uses all internal house phone wire/jacks. It just needed a three prong plug for power.
The cable at our main house is about 60% the speed of the Fios service. Verizon isn't out here yet.
Just thought I would toss it out there in case you get so fed up you want to try elsewhere. There is a 15 day no risk policy, but don't let them pull the copper from outside of the house in case you don't like the service and need to go back.
FDA panel pans Acusphere heart-imaging drug
http://biz.yahoo.com/ap/081210/acusphere_drug_fda.html?.v=2
Wednesday December 10, 4:48 pm ET
By Matthew Perrone, AP Business Writer
FDA panel says risks and uncertainty outweigh benefits of Acusphere imaging drug
WASHINGTON (AP) -- Federal advisers said Wednesday the risks of an imaging drug made by Acusphere, including abnormally low blood pressure, outweigh any advantages it has over older products.
The Food and Drug Administration's panel of heart drug experts rejected Acusphere's heart disease-screening drug Imagify by a vote of 16-1. One panelist abstained from voting.
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While the agency is not required to follow the advice of its panel, the negative opinion suggests the Watertown, Mass.-based company must clear a high hurdle to win approval of the drug.
Acusphere has several other drugs in development. But executives hope Imagify, which is part of a class of drugs called contrast imaging agents used to help diagnose heart disease, will be their first to reach the market.
Panelists were troubled by side effects reported with the drug, including low blood pressure and fainting spells.
"There is an issue with using this contrast agent and I'm bothered by it," said John Flack, professor of medicine at Wayne State University. "It's not benign and clearly there would have to be limits and restrictions on who it's given to."
Acusphere has asked the FDA to approve the injectable drug for use in patients undergoing echocardiograms, medical images of the heart. The formula includes tiny particles which improve the clarity of those images.
While several similar microbubble drugs already are on the market, Acusphere has touted its product as the first that can help physicians spot specific blood flow problems. Currently doctors use exercise stress tests combined with radiological imaging to spot such problems.
Acusphere scientists said its studies demonstrate Imagify is as accurate as radiological testing procedures, and eliminates risky exposure to radiation.
But panelists complained there was little consistency about the effectiveness of Imagify across the company's studies. They also said Acusphere should have further examined negative side effects reported among patients.
"The uncertainty on the efficacy side and the limited safety database led me to vote the way I did," said Dr. Robert Harrington, a professor of medicine at Duke University who chaired the panel.
Imagify is similar to several drugs already on the market, including General Electric's Optison and Lantheus Medical Imaging's Definity. Both include microscopic gas bubbles to improve the quality of medical images.
The agency added its most serious warning to the drugs in October 2007 after receiving about 200 reports of serious adverse reactions, seven of which caused death. In June, the FDA held a meeting to develop new safety requirements for future imaging products.
US FDA panel rejects Acusphere imaging agent
http://www.reuters.com/article/marketsNews/idINWEN164320081210?rpc=44
US FDA panel rejects Acusphere imaging agent
Wed Dec 10, 2008 4:07pm
Dec 10 (Reuters) - A U.S. Food and Drug Administration advisory panel rejected Acusphere Inc's (ACUS.O: Quote, Profile, Research, Stock Buzz) imaging contrast agent on Wednesday, saying possible risks outweighed its potential for screening heart patients.
Acusphere Inc. FDA Advisory Committee follow-up Conference Call
http://biz.yahoo.com/cc/5/99565.html
Acusphere Inc. FDA Advisory Committee follow-up Conference Call Today's Calls
Today's Calls
Call Details
Acusphere Inc. FDA Advisory Committee follow-up Conference Call
Scheduled to start Thu, Dec 11, 2008, 8:30 am Eastern
Check back at the scheduled start time for
the audio link to appear in this spot.
Add This Event To Your Yahoo! Calendar
After the event has finished, the audio will be available
from this page until Sat, Dec 12, 2009
About Acusphere Inc. (NasdaqCM:ACUS) Other Calls
Acusphere, Inc., a specialty pharmaceutical company, develops new drugs and formulations of existing drugs using its proprietary porous microparticle technology in the United States. Its porous microparticle technology enables to control the size and porosity of particles, including nanoparticles and microparticles. The company develops products in the areas of cardiology, oncology, and asthma. Its lead product candidate Imagify, a cardiovascular drug is in Phase III clinical development for the detection of coronary artery disease. The company’s products also include AI-850, a Phase I clinical trial completed product candidate that utilizes hydrophobic drug delivery system to improve the dissolution rate of a cancer drug; and AI-128, a Phase I clinical study completed formulation of asthma drug, which utilizes pulmonary drug delivery system. Acusphere has a license agreement with Cephalon, Inc. to provide license to Acusphere’s Hydrophobic Drug Delivery System for oncology applications, along with the rights to AI-850, Acusphere’s formulation of paclitaxel. The company was founded in 1993 and is headquartered in Watertown, Massachusetts.
Form 8-K for ACUSPHERE INC
http://biz.yahoo.com/e/081210/acus8-k.html
Form 8-K for ACUSPHERE INC
--------------------------------------------------------------------------------
10-Dec-2008
Regulation FD Disclosure, Financial Statements and Exhibits
Item 7.01 Regulation FD Disclosure.
On December 10, 2008, Acusphere, Inc. (the "Company") issued a press release announcing that NASDAQ has halted trading of the Company's common stock on December 10, 2008, the day of the previously announced public meeting of the Cardiovascular and Renal Drugs Advisory Committee of the Food and Drug Administration. A copy of this press release is furnished hereto as Exhibit 99.1.
This Item 7.01, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Exhibit
99.1 Press Release dated December 10, 2008, furnished herewith
Acusphere, Inc.s Stock Trading Halted Today
Acusphere, Inc.s Stock Trading Halted Today; FDA Advisory Committee Meets to Discuss Imagify
Wednesday December 10, 7:19 am ET
http://biz.yahoo.com/bw/081210/20081210005511.html?.v=1
WATERTOWN, Mass.--(BUSINESS WIRE)--Acusphere, Inc. (NASDAQ: ACUS - News) today announced that NASDAQ has halted trading in the Company’s common stock today. The Cardio Renal Advisory Committee to the U.S. Food & Drug Administration is meeting, in a public session, to review Acusphere’s lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States.
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Conference Call
Acusphere plans to hold a conference call with investors tomorrow, Thursday, December 11, 2008, commencing at 8:30 am (Eastern Time). The conference call will cover the Advisory Committee meeting, and will be led by Sherri C. Oberg, President and Chief Executive Officer and Lawrence A. Gyenes, Senior Vice President and Chief Financial Officer. These Acusphere representatives will also be available for investor questions. The conference may be heard live via the investor relations section of the Company's website at www.acusphere.com or by dialing 1-800-299-7635, or internationally 1-617-786-2901 using the confirmation code: 52594832. After the conference call, a replay of the call webcast will be made available via the Company's web site and a telephone replay will be available through January 11, 2009, by dialing 1-888-286-8010, or internationally 1-617-801-6888, using the confirmation code: 50372331.
About Acusphere, Inc.
Acusphere (NASDAQ: ACUS - News) is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology. We are focused on developing proprietary drugs that can offer significant benefits such as improved safety and efficacy, increased patient compliance, greater ease of use, expanded indications or reduced cost. Our lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, is a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States, for which a New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) in April 2008 and filed in June 2008. Imagify is designed to enable ultrasound to compete more effectively with nuclear stress testing, the leading procedure for detecting coronary artery disease. It is estimated that more than 10 million procedures are done each year in the U.S. to detect coronary artery disease, the leading cause of death in the United States. The Company estimates that the potential annual U.S. market opportunity for Imagify exceeds $2 billion. Imagify and the Company's other product candidates were created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microspheres in a versatile manner that allows them to be customized to address the delivery needs of a variety of drugs. For more information about Acusphere visit the Company's web site at www.acusphere.com.
"Acusphere" and "Imagify" are trademarks of Acusphere, Inc.
Contact:
Company:
Acusphere, Inc.
Lawrence A. Gyenes, 617-648-8800
Chief Financial Officer
or
Media:
HealthStar Public Relations
Dave Schemelia, 609-468-9325
or
Investors:
Acusphere, Inc.
617-925-3444
IR@acusphere.com
Sherri and crew were very specific that CEHP would be held "at arms length" for any negotiations for Imagify if they went with option II.
I think that one of the callers even asked for clarification on the point, and again were told that they would not get to vote on the future of Imagify if they choose option II.
I don't have the energy to re-listen to the last call, but maybe someone else can back up my memory. God knows I need it!
It might be buried in that S8 addendum where the 20% royalty came from, but that is a WAG.
Take Care GFP, hope you were long some big names today, they did well.
There is no mention of a vote in the Agenda documents currently out from the FDA.
I keep reading that "typically" there is a vote on the day of the advisory meetings, but it is not listed, so I thought I would mention it.
I will have to sledge hammer my computer if I haven't seen anything by 9:29 Thursday morning@#$@!!
Does anyone know an approximate percentage of the time an advisory panel actually votes on the day of the meeting?
Convert would have been a much better word, agreed. But i guess i was thinking that the 15 mil wouldn't have to be paid back, so they were really buying it. As i was heading to the beach, I thought that something in that post didn't add up, but that wasn't it, and now i can't remember what it was! I haven't even started any "gfp" therapy in liquid form!
That said, if ceph does go with option II, then acus is free to market Imagify to anyone it pleases, and Ceph board members get no vote in those negotiations. Assuming Imagify is first, not recommended by this panel, and then not worth reviving at all, then that is a moot point.
Still i haven't lost anything until i sell. I won't be selling before the vote, at least i can't imagine i would. I have half-a** figured my buy-in average at .42 or so, but that is give or take a few cents. To think I could have saved all those months and just bought today! Ahh, but then I wouldn't have been in the game should it have gone the other way.
Of course now thinking of what i could have bought with those 10's of thousands of dollars i left on the table, assuming I could have sold without driving the price down last Friday. With a surprise recommendation, it could be positive hundreds of thousands. Just paper for now, worth it all the way for me.
Take Care.
Absolutely, I bought more this morning at .311.
It is all money that I don't need to see again. But obviously I would rather not lose it!!!!
The only shares I sold were 10K back when the market was tanking during a late afternoon session and there was fear everywhere. Usually I can rise above that kind of stuff, but so many big firms were in trouble, it got the best of me that day.
I didn't quite get to a double on Friday, so I held.
Oh, but for hindsight
I am heading out today, just to get away from the stress. I would rather be blistfully ignorant until the panel votes. (though I actually feel that way a lot of the time
Take Care.
A little early for "toast" imo. They still have to meet, and then vote. In a couple days the smell of burning bread might be in the air, but I still have hope. I am sure it has nothing to do with my large, for me, current position
Perhaps the worst case, a no confidence vote, ceph goes option II, buys 51% of acus, and then likely buys out the remainder at some point in the future.
Guess it all depends on your average in price.
Take Care.
Somewhat, There was mention made in the last conference call, I believe. Stress of keeping up with this mornings developments has thrown off my compass, as you can imagine, but we were reminded that these were patients, many of whom were having chest pain, as is the case with a lot of cardio cases.
It will be an interesting few days for sure!
Take Care.
Here is Acusphere's Response Document:
http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4390b1-03-Acusphere.pdf
OUCH!
I wonder why CEPH, with the Founder of CEPH sitting on ACUS's board, would invest in the rights to Imagify, just weeks before this meeting, without some chance to get a positive review?
I just bought more at .311.
Could easily lose it all.