Erfolgt hier bald die Zulassung??
Na jetzt müssen wir doch noch auf weitere News warten.
Aber ich bin zuversichtlich, denn ich glaube nicht, dass HEB einfach mal Millionen aus dem fenster schmeißt...
Hemispherx Biopharma Inc.’s board of directors on Wednesday approved plans to spend up to $4.4 million on upgrades to its North Jersey plant to enhance production of three products.
Only one of the products, the genital warts treatment Alferon N, has Food and Drug Administration approval.
The FDA is reviewing a new drug application submitted by Philadelphia-based Hemispherx (NYSE Amex:HEB) for a second product, Ampligen, a potential treatment for chronic fatigue syndrome.
Ampligen and the third product, Alferon LDO, are also being looked at for other indications including the prevention and treatment of both seasonal and pandemic influenza.
Hemispherx’s 43,000-square-foot manufacturing site is New Brunswick, N.J.
The company said details on the use of its experimental therapeutics is ongoing and projected clinical trials will be presented at upcoming health-care conferences.
http://zikkir.com/health/2958
Naja...abwarten, pre-market geht in den USA schon wieder zurück
Aber ich warte, auf jedanfall dieses Jahr ab....:-))
Study Isolates Virus in Chronic Fatigue Sufferers
By David Morgan
October 8, 2009
http://abcnews.go.com/Technology/WireStory?id=8783360&page=1
HEB ==> http://www.hemispherx.net/content/rnd/cfs.htm
HEB - Clinical Trial http://www.hemispherx.net/content/rnd/clinical_trials_cfs.htm
BIOMED-REPORT
Study Isolates Virus in Chronic Fatigue Sufferers
Written by Staff and Wire Reports
Thursday, 08 October 2009 11:38
http://biomedreports.com/articles/most-popular/...igue-sufferers.html
Last: $ 1.08 Pre-Market
High: $ 1.28
Pre-Market
Volume: 117,027 Pre-Market
hab es leider verpasst zu verkaufen, war vor monaten bei 0,67 (euro!) reij und sitze auf den teilen :/
Federman & Sherwood Announces That a Securities Class Action Lawsuit Has Been Filed Against Hemispherx Biopharma, Inc. (AMEX: HEB)
- Press Release
- Source: Federman & Sherwood
- On 4:27 pm EST, Friday December 4, 2009
OKLAHOMA CITY, OK--(Marketwire - 12/04/09) - On November 10, 2009, a class action lawsuit was filed in the United States District Court for the Eastern District of Pennsylvania against Hemispherx Biopharma, Inc. (AMEX:HEB - News). The complaint alleges violations of federal securities laws, Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5, including allegations of issuing a series of material misrepresentations to the market which had the effect of artificially inflating the market price. The class period is from February 18, 2009 through November 2, 2009.
Plaintiff seeks to recover damages on behalf of the Class. If you are a member of the Class as described above, you may move the Court no later than Monday, January 11, 2010, to serve as a lead plaintiff for the Class. However, in order to do so, you must meet certain legal requirements pursuant to the Private Securities Litigation Reform Act of 1995.
If you wish to discuss this action, participate in this or any other lawsuit, or have any questions or concerns regarding this notice, or preservation of your rights, please contact:
Contact:
William B. Federman
FEDERMAN & SHERWOOD
10205 North Pennsylvania Avenue
Oklahoma City, OK 73120
Email to: wbf@federmanlaw.com
www.federmanlaw.com (Quelle: http://finance.yahoo.com/news/...wood-iw-3189990983.html?x=0&.v=1 )
anderseits Aufstocken bei den Bosses... Insidertrade, die kaufen ein...
http://www.streetinsider.com/Insider+Trades/Hemispherx+%28HEB%29+Execs+Empty+Their+Piggy+Banks+To+Buy+Some+Stock/5167946.html
Hemispherx (HEB) Execs Empty Their Piggy Banks To Buy Some Stock
Hemispherx Biopharma, Inc. (NYSE: HEB) Medical Director David Strayer bought 12,000 shares
on 12/07 at $0.5654 per share, bringing his stake to 51,246 shares.
This purchase follows the disclosed purchase of 30,000 shares by CEO Carter yesterday.
It should be noted that the dollar amount of these trades is very low, with today's disclosure about $6K. Excuse me sir, do you need to margin that?
http://www.streetinsider.com/Corporate+News/Hemispherx+Biopharma+%28HEB%29+Receives+Letter+for+Ampligen+From+US+FDA%3B+FDA+Cannot+Approve+Application+in+Present+Form/5150673.html
Hemispherx Biopharma (HEB) Receives Letter for Ampligen From US FDA; FDA Cannot Approve Application in Present Form December 1, 2009 4:35 PM EST
Hemispherx Biopharma, Inc. (AMEX: HEB) announced that it received a Complete Response Letter from the U.S. Food and Drug Administration which describes specific additional recommendations related to the Ampligen 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. Most notably, the FDA stated that the two primary clinical studies submitted with the NDA did not provide credible evidence of efficacy of Ampligen 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 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 manufacturing noting the need to resolve outstanding inspection issues at the facilities producing Ampligen. 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 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 NDA.