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I thought they said no already
did they say no or yes because I sold
IS IT DONE
checking on that one
EVERYONE THE ISSUE WAS LEVEL 2 ON AMERITRADE ACCOUNTS NOW IT IS UP
HEHE GOING UP
nothing has changed going to uptick here
buying more bounce coming
It's trading
.01 today more news on it's way
my same vote how long does it take for the meeting?
if they reduce the outstanding with preferred shares the price will spike up
now your talking just taking a chance is why I'm here we will see I'm not here to decipher all the documents let the FDA scamsters determine what they feel is correct.
not my job to figure it out it's my job to take the calculated chance. Many feel they have it figured out but only time will tell. Even if we do guess right it's still just that a guess.
not worried I just want the yes and the rest will take care of it's self
I bought in today we will see I'm a betting man so I will be happy either way buy when everyone else is selling
if your right I will be the first to say it if we win the vote for HEB I expect the same thing
HEB will prevail and thestreet.com lied to the SEC and had to settle today read the news thanks. This is just thestreet.com opinion letter not official
by aggiebioengineer . 39 minutes ago . Permalink
How about your common cold medicine? They contain acetaminophen, which cause serious (possibly fatal) liver disease, even caused several deaths. Acetaminophen is also present in just about every pain killer and anti-inflammatory pills.
Wow same info from 2009 we already knew this and this is why people sold today it will bounce hard.
Hemispherx Biopharma Receives Complete Response Letter From FDA on Ampligen(R) New Drug Application for Chronic Fatigue Syndrome
PHILADELPHIA, Dec. 1, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company" or "Hemispherx"), announced that it received a Complete Response Letter from the U.S. Food and Drug Administration ("FDA") which describes specific additional recommendations related to the Ampligen(R) NDA. In accordance with its 2008 "Complete Response" procedure, the FDA reviewers determined that they cannot approve the application in its present form and provided specific recommendations to address the outstanding issues. Hemispherx is carefully reviewing the Complete Response letter and will seek an expedited meeting with the FDA to discuss its recommendations. Management is pleased to have received specific advice on the remaining issues and is looking forward to making a thorough but expedited response its top priority, and plans to take all appropriate steps to seek approval and commercialization of Ampligen(R).
Most notably, the FDA stated that the two primary clinical studies submitted with the NDA did not provide credible evidence of efficacy of Ampligen(R) and recommends at least one additional clinical study which shows a convincing effect and confirms safety in the target population. The FDA indicated that the additional study should be of sufficient size and sufficient duration (6 months) and include appropriate monitoring to rule out the generation of autoimmune disease. In addition, patients in the study should be on more than one dose regimen, including at least 300 patients on dose regimens intended for marketing. Finally, the additional study must incorporate both a well-controlled QT interval study and pharmacokinetic evaluations.
Other items required by the FDA include certain aspects of Non-Clinical safety assessment, and Product Quality. In the Non-Clinical area, the FDA is recommending that the Company complete rodent carcinogenicity studies in two species. As part of the NDA submission, the Company had requested that these studies be waived, but the waiver has not been granted. Certain additional non-clinical studies and additional data to support non-clinical studies already submitted with the NDA are also recommended by the FDA. Prior to the receipt of the Complete Response letter, the Company had already begun many of these additional studies and the collection of the requested additional data.
Under the Product Quality section of the Complete Response letter, the FDA recommends that the Company submit additional data and complete various analytical procedures. The collection of these data and the completion of these procedures is already part of the Company's ongoing Quality Control, Quality Assurance program for Ampligen(R) manufacturing under cGMP (current Good Manufacturing Practice Guidelines) and the manufacturing enhancement program recently undertaken by the Company and announced in a news release on September 16, 2009.
Finally, the FDA commented on Ampligen(R) manufacturing noting the need to resolve outstanding inspection issues at the facilities producing Ampligen(R). These include the Company facility located in New Brunswick, NJ and one of the Company's third party manufacturing facilities (Hollister-Stier Laboratories). The Company has been working to resolve these issues.
At this time the Company's management has not determined the impact of the additional recommendations set forth in the Complete Response letter on the timelines and overall cost of the Ampligen(R) program, but the Company's management has made response to the issues and satisfaction of any additional requirements a top priority. The Company will seek to meet with the FDA to clarify any issues identified in the Complete Response letter and to work with the FDA to identify the most expeditious path to satisfaction of the requirements for approval of the Ampligen(R) NDA.
10 Yes's 4 No's HEB to $2
Not my DD but someone from YMB and I started to buy yesterday at .65 I'm glad I waited until today I feel this will shoot up quick
WITH FDASIA THE FDA CAN APPROVE AMPLIGEN RIGHT NOW WITH JUST THEIR PHASE II DATA + CONDITIONS
by jay_kome
Look at the news on the street.com they just settled a case with the sec and they call heb management liars wow hypocrites
not legitimate imo this is why I bought
because of this letter is why I bought it today
please sell me some at .0014
HXPN 12 million share float super news just reinstated huge gapper
HXPN 12 million share float super news just reinstated huge gapper
That would be super nice
HPXN will go boom with only 12 million share float
very informative thanks and here's to VRNG
Ready to get this baby really going .50 to 1 easy once the news starts flowing
hey did you hear back from the company
Our bid is higher point blank
Legit question from a smaller company that has investors to buy tullys so mute point now
When they win the bid they will
I hope it does I want more before next month
BCCI News this morning huge
time will tell