CEL-SCI CORP. DL-01 (WKN: 871006)

Guten Morgen,

macht es Sinn die Aktie in Deutschland zu ordern, oder würdet ihr USA vorziehen.
Lohnt der Einstieg noch? Danke vorab für ne kurze Info.

Viel Glück allen Investierten.

Harry  

Wie kommst Du auf 8$???

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Um für die FDA voll gerecht zu einer nächsten Phase der klinischen Studie zur LEAPS H1N1-Behandlung von stationären Patienten mit Labor-Bewertung bestätigt H1N1-Pandemie-Grippe im Rahmen eines Exploratory IND, hat die FDA bat CEL-SCI um eine detaillierte Follow-up regulatorischen Einreichung mit umfangreiche weitere Daten. Thus, in parallel with ramping up its first study, CEL-SCI is proceeding on an expedited basis with the substantial undertaking necessary to complete this next submission. So wird parallel baut seine erste Studie, CEL-SCI Verfahren in einem beschleunigten Verfahren mit den wesentlichen Unternehmens erforderlich sind, um diese nächste Einreichung abzuschließen. Recognizing that it cannot proceed with its next-stage clinical trial without the Agency's concurrence, CEL-SCI anticipates engaging in a detailed dialogue with FDA regarding the proposed LEAPS-H1N1 clinical-development program based upon this future filing. Der Erkenntnis, dass es nicht mit der nächsten Phase der klinischen Prüfung ohne Zustimmung der Agentur, CEL-SCI gehen kann erwartet den Eintritt in einen ausführlichen Dialog mit der FDA über die angebotene LEAPS-H1N1-klinischen Entwicklungsprogramm auf diese Zukunft Anmeldetag beruht.

http://www.finanznachrichten.de/...zed-h1n1-infected-patients-008.htm

As consumers anxiously await availability of an H1N1 vaccine, one Washington-area biotech is moving forward with trials of a treatment for the disease.

Vienna-based Cel-Sci Corp. (NYSE Amex: CVM) announced Wednesday that the Food and Drug Administration has indicated that the company can proceed with its first clinical trial to evaluate the effect of its investigational H1N1 treatment on the white blood cells of hospitalized patients. Cel-Sci said that initiation of the study is subject to institutional review board review and approval.

Cel-Sci said that as it ramps up this first study it is already making preparations for a next-stage trial and putting together a requested follow-up regulatory filing with extensive additional data for the FDA. The company said that it anticipated extensive discussions with the FDA regarding the proposed LEAPS-H1N1 clinical-development program based upon this future filing.

LEAPS technology is a novel T-cell modulation platform technology that enables Cel-Sci to design and synthesize, non-recombinantly, proprietary immunogens. The LEAPS technology combines a small peptide that activates the immune system with a small peptide from a disease-related protein, such as the H1N1 hemagglutinin molecule, to make an investigational product that induces defined immune responses.

"Cel-Sci recognizes the importance of not only developing, but extensively testing an intervention that has the potential to treat pandemic flu," said Cerl-Sci CEO Geert Kersten. “As we prepare to initiate our first study, Cel-Sci expects to work closely with the FDA and experts in the field in developing the necessary data and appropriate protocols to ensure that we rigorously meet the FDA regulatory requirements,” Kersten said.

http://www.bizjournals.com/washington/stories/...51.html?surround=lfn

 

http://de.advfn.com/p.php?pid=qkchart&symbol=A^CVM  

(RTTNews) - Wednesday, CEL-SCI Corporation (CVM: News ), a developer of vaccines and cancer drugs, said the U.S. Food and Drug Administration, or FDA, has indicated the company can proceed with its first clinical trial to evaluate the effect of its investigational LEAPS-H1N1 treatment on the white blood cells of hospitalized H1N1 patients. The company's shares are trading up more than 20% on the AMEX.

The company said the FDA indication followed the responsive and expedited initial review of its regulatory submission for this study proposal. Following completion of manufacturing, initiation of the first study is subject to IRB review and approval, said the company.

In order to fully consider a next-stage clinical trial to evaluate LEAPS-H1N1 treatment of hospitalized patients with laboratory-confirmed H1N1 Pandemic Flu under an Exploratory IND, FDA has asked the company to submit a detailed follow-up regulatory filing with extensive additional data.

Going on with the first study, the company is simultaneously proceeding on an expedited basis with the substantial undertaking necessary to complete this next submission. Further, CEL-SCI said it anticipates engaging in a detailed discussion with FDA regarding the proposed LEAPS-H1N1 clinical-development program based upon this future filing.

Weiter.......................
http://www.rttnews.com/ArticleView.aspx?Id=1068236

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jetzt sogar ins Minus gerutscht  

Direct Offering

VIENNA, Va., Sept. 16 /PRNewswire-FirstCall/ -- CEL-SCI Corp. (NYSE Amex: CVM), a developer of vaccines and therapeutics for the prevention and treatment of infectious diseases and a late-stage oncology company, has entered into definitive agreements to sell 14,285,715 shares of its common stock at a price per share of $1.40 pursuant to a registered direct offering to institutional investors, representing gross proceeds of approximately $19 million.

Investors will also receive warrants to purchase 4,714,284 shares of CEL-SCI Corporation's common stock. The warrants have an exercise price of $1.50 per share and are exercisable at any time after the closing of the transaction and before the second anniversary of such initial issuance date. The closing of the offering is expected to take place on or before Monday, September 21, 2009, subject to the satisfaction of customary closing conditions. CEL-SCI Corporation plans to use the net proceeds from the offering to commence a pivotal Phase III clinical trial with its cancer drug Multikine and to rapidly take its new LEAPS - H1N1 compound into human studies for the treatment of hospitalized H1N1 patients.

The shares and warrants are being offered by CEL-SCI Corporation pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission dated August 12, 2009. Rodman&Renshaw, LLC, a wholly owned subsidiary of Rodman&Renshaw Capital Group, Inc. (Nasdaq GM: RODM - News), acted as the exclusive placement agent for the transaction.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The shares of common stock may only be offered by means of a prospectus. Copies of the final prospectus supplement and accompanying base prospectus can be obtained from the SEC's website at http://www.sec.gov/.

About CEL-SCI:

CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine which is being readied for a global Phase III trial in advanced primary head and neck cancer. CEL-SCI is also developing a vaccine to prevent and treat swine and other influenzas using its L.E.A.P.S. technology platform and expects to soon finish the validation of its state-of-the-art facility in Maryland which it expects to utilize to launch aseptic filling for stem cell produced therapies and other biological products. The Company has operations in Vienna, Virginia, and Baltimor
http://www.finanznachrichten.de/...registered-direct-offering-008.htm

http://www.finanznachrichten.de/...registered-direct-offering-020.htm

Cel-Sci Corp. and Novavax Inc., both developing swine flu-related products, have each indicated plans to sell stock to raise a combined $30 million in financing, joining other area money-raising biotechs after nearly a yearlong dry spell in the life sciences capital markets.

Cel-Sci (AMEX: CVM) is capitalizing on a 58 percent spike in its stock price in the last two days from news of upcoming tests of its H1N1-fighting technology. The Vienna company now said it plans to raise $20 million in gross proceeds from sales of nearly 14.3 million shares of its stock at $1.40 apiece.

That price reflects trading highs of Cel-Sci, whose share price hadn’t topped $1 in more than three years until this week. The company announced today that the Food and Drug Administration gave it a green light to start testing its experimental LEAPS-H1N1 treatment on the white blood cells of hospitalized H1N1 patients.

Cel-Sci said it hopes to close on the registered direct offering, for which Rodman & Renshaw LLC is the placement agent, by Sept. 21. After expenses, the company expects to make $19 million in net proceeds, which it said it would spend on its human clinical tests of its swine flu treatment, as well as on long-planned final human drug trials of its flagship anticancer Multikine product.

Rockville-based Novavax has submitted a regulatory filing that registers up to 3.4 million of its shares for a later stock sale. While the vaccine company, which has also recently released preliminary positive results of an experimental H1N1 vaccine, hasn’t set a date for any stock sale, it inked an agreement Tuesday with placement agent William Smith & Co. to sell up to $10 million worth of shares in the future.

The two companies are following in the footsteps of other local biotechs, both mammoth and miniscule, that have managed to shove open Wall Street’s formerly locked doors for much-needed financing. In the last two months, GenVec Inc. (NASDAQ: GNVC), Human Genome Sciences Inc. (NASDAQ: HGSI), Micromet Inc. (NASDAQ: MITI) and Cytomedix Inc. (AMEX: GTF) have sold stock to raise anywhere from $1.5 million to $358 million.

The activity suggests some loosening of capital markets, which industry observers say are taking greater notice of headline-making biotechs with positive drug test results or high-interest products in fields like swine flu. For many local biotechs that had been painfully short of cash since the recession hit, this is welcome news.

“There’s value when you have good science, and that’s absolutely the time to monetize that,” said David Moskowitz, a research director in the Vienna office of investment bank Caris & Co., based in Del Mar, Calif. “It does look as if the window is opening partially. It’s just the beginning. We’ll see how the rest of the year plays out.”

http://washington.bizjournals.com/washington/...y74.html?surround=lfn

LOS ANGELES, CA--(Marketwire - September 17, 2009) - BioMedReports.Com, the news portal which covers Wall Street's biomedical sector and delivers financial and investment intelligence to a community of highly informed investors, has issued a special news report on key developments at CEL-SCI Corporation (NYSE Amex: CVM).

In a series of news making headlines the company has positioned themselves to quickly capitalize on opportunities in not only the H1N1 Flu space with backing from the FDA, but they have also now raised enough money to move ahead with the company's long awaited and highly anticipated PHASE III trials of their flagship cancer treatment, Multikine® -- a first of its kind immunotherapeutic agent being developed as a standard of care cancer treatment which analysts believe will attain "blockbuster drug" status.

For better or worse, news of the company's novel H1N1 flu treatment for already infected patients has pushed CEL-SCI to one of the heaviest traded sectors in the biotech market. The company is officially a "swine flu play," but it seems investors are not as easily willing to part with their shares since getting yesterday's FDA go-ahead validation. Has CEL-SCI managed to set themselves apart in a field of populous pretenders touting less impressive technologies?

In the report, company CEO, Geert Kersten says: "Many people think that all this news about H1N1 vaccines being approved is a good thing and that the danger posed by swine flu is no longer something to worry about, but nothing could be further from the truth.

"A great many people in the medical community and in the government are still very worried -- especially since new poll data shows that many people are afraid to take the new vaccines and over 80% of them don't plan to. That will pose some serious issues. That's why we're dealing with a treatment option and that's why the FDA has been very receptive to what we're doing."

http://www.marketwire.com/press-release/...NYSE-Amex-CVM-1045984.html

Swine Flu

“The Obama administration is very worried that this could turn into a double dip (double bottom) recession,” said one person familiar with this situation. “They are doing everything they can to ensure that the H1N1 pandemic is not the catalyst for just such an event.”

http://seekingalpha.com/article/...-sci-against-swine-flu?source=feed

For years, it seems, CEL-SCI's (CVM) investors have been waiting for this perfect storm of positive developments.

The company was so badly beaten and on the ropes recently, that most of the management team continued to work, for extended periods of time, without compensation. "When I came home and told my wife about the pay cut, she looked at me as if I was crazy," says CEL-SCI's CEO, Geert Kersten.

"Still, the team stuck together and we are finally to a point where our vision is starting to come together."

Kersten's team is one of the most loyal groups in biotech. Investors would be hard pressed to find any group at a company of this size which has logged the kind of time and mileage that they have together - all of it with very little turnover.

Perhaps this is why Kersten is the first to give credit to the rest of his team for some of the impressive news-making headlines the company has made during the last couple of days. For years, he has been quietly working to raise enough money to move ahead on the company's highly anticipated PHASE III trials of their flagship cancer treatment, Multikine®- the first immunotherapeutic agent being developed as a standard of care cancer treatment.

In Phase II clinical trials, the compound was demonstrated to be safe and well-tolerated, improving patient overall survival 33% at a median of three-and-a-half years following surgery. Multikine® advanced into a Phase III clinical trial in January 2007, but technically, those trials only began on paper. Even as the product was granted orphan-drug status by FDA in May 2007 and industry analysts predicted that it would garner FDA approval and break the annual billion-dollar sales barrier, the company struggled to survive.

While we will write more about that unlikely journey in days to come, it’s important to note two significant developments that have propelled shares of the company from a mere $.28 in June to a close of $1.32 at the end of Wednesday's session.

First came news that the company was having closed door meetings with government officials who were interested in the company’s work on a somewhat secretive treatment for patients infected with H1N1 (Swine Flu) virus.

As my first investigative report (filed in late July) documented, the company was busy working on a novel approach to deal with the ever changing enemy known as the influenza virus.

Our second report uncovered filings that confirmed that CEL-SCI had indeed been quietly positioning itself as a player in the H1N1 space with solutions aimed to get the attention of parties at the CDC, FDA and beyond.

Then two days ago, we broke the story that the company had been holding meetings with various public (and not-so-public) government agents who are increasingly worried about the health and economic impact of the global pandemic. The stock surged as the story and rumors spread faster that the flu itself. Even the Wall Street Journal took note of the investigative report.

Less than 24 hours later, the company released news that the company's H1N1 treatment has been granted special expedited review by the FDA. Now, it appears that CEL-SCI is the only company developing an actual treatment for very ill patients already infected with H1N1. Imagine the medicinal and financial impact a drug like that might have and it's easy to understand how just hours later, investors showed up on CEL-SCI’s doors ready to inject roughly $19 million in a deal which Kersten describes as “extremely favorable” to the company.

Suddenly, the little company everyone had forgotten about is back in the game. Just like that.

And what usually takes years is suddenly taking place very quickly, due mostly to the “outside the box” thinking of CEL-SCI’s management team.

Ever mindful that the FDA was going to be extraordinarily flexible in evaluating vaccines for pandemic influenza, the company went to work on an investigational H1N1 treatment for hospitalized H1N1 patients. While the treatment is based on the company’s proprietary L.E.A.P.S. ™ platform, one medical expert familiar with the technology calls it’s not only “brilliant,” but also “something no one else has thought of.... Especially none of the big pharmas.”

That has to sound like music to investors’ ears. Especially knowing that today’s biggest innovations from smaller companies like CEL-SCI, make for big acquisiton targets and big premiums for shareholders.

While the CEO is willing to tell us that the company has immediately begun trials with human blood, he is still a bit worried about saying too much about the technology itself.

“The truth is, this is a very novel approach and it could be a game changer,” explains Kersten. “At the same time, we have to be very protective of the technology and we will likely not be publishing much about it –even if gets fast track approval. The patent process in many countries simply doesn't work as quickly as the drug approval process. It can take years to secure all the protections we need on a global scale and we don’t want to risk the possibility of copycats stealing our approach and technology. We have to be very protective of our investors.

“Ultimately this is about giving people a fighting chance to survive."

While there is some confusion about whether CEL-SCI had been developing an H1N1 and Avian flu vaccine or an actual treatment, Kersten tells us that the drug is defeinitely a treatment: "It is a vaccine in the same sense of what many people might call a ‘cancer vaccine,’ for example. Now is a cancer vaccine really a vaccine or is it really a treatment? I think we'd all agree that it is definitely a treatment, that may be where some of the confusion is coming from.”

Whatever it is, the company is wasting no time and the new compound, which has tested well in animal models is now being tested on human blood and shortly after will be tested on very sick, infected patients.

“The FDA has been very respectful and they have told us to expect complete collaboration with us on moving this forward,” says Kersten. “They want us to move ahead very quickly and now we've armed ourselves with the tools to do that."

According to a briefing document from the FDA's Center for Biologics Evaluation and Research Office of Vaccines Research and Review which was discussed and published earlier this summer, normal clinical trials are usually completed before the FDA will even accept an application for a drug or vaccine. But given the perceived urgency of the H1N1 situation, the agency is leaning toward approving vaccines based on incomplete or very small studies. Kersten says his company is hoping for the same type of outcome for CEL-SCI’s treatment.

“Many people think that all this news about H1N1 vaccines being approved is a good thing and that the danger posed by swine flu is no longer something to worry about,” explains Kersten. “Nothing could be further from the truth.

“A great many people in the medical community and at the highest levels of government are very worried. Especially since newly released poll data shows that most Americans are afraid to take the new vaccines and over 80% of them don’t plan to do so. That will pose some serious issues to our entire medical infrastructure. That’s why we’re dealing with a treatment option and precisely why the FDA has been very receptive to what we’re doing.”

For better or worse, news of the company's novel H1N1 flu treatment for already infected patients has has pushed CEL-SCI to one of the heaviest traded sectors in the biotech market- the “swine flu play.” It seems, however, that investors are not as easily willing to part with their shares since getting yesterday’s FDA go-ahead validation. Has CEL-SCI managed to set themselves apart in a field of populous pretenders touting less impressive technologies?

Even as the company made public their plans to raise $20 million in gross proceeds from sales of nearly 14.3 million shares of its stock at $1.40 apiece, the usual “sell-off” on that type of news barely had an impact. Compare that to the price action of fellow successful swine flu stock, Novavax. After that company announced plans to raise only half as much money on Wednesday, NVAX shares took an immediate beating and continued trading down after hours. CEL-SCI shares closed ony four cents lower than the previous day and were seen swapping as high as $1.68 during after hours trading.

That difference in perception and investors' bullish sentiment are most likely due to the fact that Kersten and company announced that the newly raised funds will now enable the company to finally commence PHASE III trials of Multikine ®. Part of the proceeds will also be used immediately to move the much touted H1N1 treatment into human trials at break-neck speed.

“It’s great news for everyone,” says Kersten. “I usually get angry calls from investors complaining that we've impacted share prices by raising that kind of money, but usually within a couple of days we find that the shares start trading at much higher levels than they were before and everyone is happy. We hope to see that this time around as well. These are very exciting times for our company.”

These price reflects trading highs of the stock, whose price hadn’t topped $1 in more than three years until this week.

Indeed, it looks like the sun is finally breaking the dark cloud cover above and CEL-SCI may finally see the brighter days that investors and company officials have all been waiting for- for so long.

http://seekingalpha.com/article/...omentum-keeps-building?source=feed

da weiß jemand mehr...
Einen erfolgreichen Tag
&
erholsames Weekend!  

Bin soeben auch eingestiegen!  

 

macht gleich 1,27 Euro Leute. Warum verkauft Ihr so billig? Abwarten, sich zusammenreißen und schauen was gegen 15:30 in USA los ist.

Meine Meinung, keine Empfehlung.

 

weil ja einige meinen, sie müßten ein paar cents Gewinne realisieren. Die werden sich noch wundern in welche Höhen sich der Kurs bewegen wird.

Mir selbst ist das auch schon passiert. Ungeduldig, Gierig und ohne nachzudenken verkaufen und dann vor lauter Panik zusehen wie aus 100% 250% und mehr werden und den Einstieg nicht mehr schaffen. Mann oh mann.

Jetzt Cool bleiben und laufen lassen....

Meine Meinung, Erfahrung und keine Empfehlungen an andere.

 

http://biomedreports.com/component/content/...scis-h1n1-flu-play.html  

Oder liegt das an den Kursrücksetzern, die wir die letzten 2 Tage erlebt haben. Völlig normal und gesünder als 60-70% Steigerungen an einem Tage.

Heute gehts wieder rauf, da Einsteigerkurs vorliegt.

Meine Meinung, keine Empfehlung.