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NexMed Receives FDA Clearance for PrevOnco™ Phase 2 Study as First-Line Therapy for HCC
-FDA Also Provides Opportunity to Move Directly Into Phase 3 Study to Test PrevOnco™ as Second-Line Therapy for NEXAVAR®-
SAN DIEGO--(BUSINESS WIRE)--NexMed, Inc. (NASDAQ: NEXM), a specialty CRO with a pipeline of products based on the NexACT® technology, today announced that the U.S. Food & Drug Administration (FDA) has cleared the Company to proceed with the proposed Phase 2 trial of PrevOnco™, its proprietary cancer treatment for patients with advanced, unresectable hepatocellular carcinoma (HCC), or liver cancer. The FDA granted PrevOnco™ orphan drug status in August 2008, and in March 2010, NexMed filed its Investigational New Drug (IND) application for the product candidate.
The Company also noted that in IND review communication, the FDA has given NexMed the opportunity to move PrevOnco™ directly into a Phase 3 trial that would support marketing approval, subject to positive study results. In order to pursue this regulatory path, NexMed would need to expand the proposed Phase 2 study design to use PrevOnco™ in combination with Doxorubicin as a second-line therapy for patients who have failed NEXAVAR®, the currently marketed first-line anticancer treatment for patients with either HCC or advanced renal cell carcinoma (cancer of the kidney).
PrevOnco™ incorporates lansoprazole, which is the generic anti-ulcer compound approved under the name Prevacid® and marketed in the U.S. by Takeda Pharmaceuticals North America, Inc. In vitro and in vivo data generated to date has demonstrated the ability of lansoprazole to inhibit tumor cell growth and enhance survival in mouse models of cancer alone, and in combination with Doxorubicin.
Commenting on today’s news, Dr. Bassam Damaj, President and Chief Executive Officer of NexMed, stated, “We are very pleased that the FDA agreed with our protocol for the HCC Phase 2 trial for PrevOnco™ as a first-line therapy for HCC. Additionally, we are actively assessing the suggestion made by the FDA to move directly into a Phase 3 trial, by studying PrevOnco™ in combination with Doxorubicin as a second-line therapy for patients who have failed NEXAVAR® therapy. Following this path could be very advantageous for NexMed since advancing the drug directly into a Phase 3 study would save us at least 12-24 months in development time.”
About Hepatocellular Carcinoma (HCC)
Hepatocellular carcinoma (HCC) is the seventh most common cancer in the world, with a high incidence in China and other Asian countries. Although uncommon in the U.S., there are a reported 8,500 to 11,000 new cases diagnosed each year, comprising 2% of all malignancies. Cases in the U.S. occur primarily in men of Chinese descent, a subpopulation which has a high incidence of viral hepatitis – a known risk factor for HCC.
About NexMed, Inc.
NexMed is the largest specialty CRO based in San Diego, CA and is one of the industry's most experienced CROs for in vitro and in vivo pharmacology services and research models. The Company’s goal is to generate revenues from the growth of its Discovery Pre-clinical CRO business, while aggressively seeking to monetize its proprietary NexACT drug delivery technology through out-licensing agreements with pharmaceutical and biotechnology companies, worldwide. At the same time, NexMed is actively pursuing partnering opportunities for its NexACT-based treatments for onychomycosis, psoriasis, sexual dysfunction and cancer. For further information on NexMed and its subsidiaries, visit the following websites: http://www.nexmed.com or http://www.bio-quant.com.
Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company including but not limited to its ability to develop and license PrevOnco™ and the ability to design and commence clinical studies.
Contacts
NexMed Contacts:
NexMed, Inc.
Edward Cox, 858-926-5811
V.P. Investor Relations
ecox@nexmed.com
or
NexMed Investor Relations:
Rx Communications Group, LLC
Paula Schwartz, 917-322-2216
pschwartz@rxir.com
big jump on NEXM today
it may run very hard today.
i know the shorts who were waiting for a no profit report have to cover now.
might be a hell of short squeeze.
keeps on moving up as we get closer to earnings
okay now it's down through .50 think were not going anywhere today. very sad
looks like it's leveling off. consolidation may be done.
looking for FDA approval news.
here we go again !! looking for it to break higher!!
breakout here.
jumped on board here. looks good for a push through .80 and then it should be able to move up nicely
- Withdrawal of Registration Statement (RW)
CORD BLOOD AMERICA, INC.
1857 Helm Drive
Las Vegas, NV 89119
Via Edgar
December 29, 2009
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street N.E.
Washington D.C. 20002
Re: Cord Blood America, Inc.
Request to Withdraw Registration Statement on Form S-1 (RW)
SEC File Number: 333-162832
Ladies and Gentlemen:
Pursuant to Rule 477(a) promulgated under the Securities Act of 1933, as amended (the "Securities Act"), Cord Blood America, Inc. (the " Registrant") hereby requests immediate withdrawal of its Registration Statement on Form S-1 (File No. 333-162832 ), which was originally filed with the Securities and Exchange Commission (the "Commission") on November 2, 2009, along with any exhibits (the "Registration Statement"). No securities have been issued under this S-1 Registration Statement.
The Registrants believes that withdrawal of the Registration Statement is consistent with the public interest and the protection of investors. The Registrant requests, in accordance with Rule 457(p) under the Securities Act that all fees paid to the Commission in connection with the filing of the Registration Statement be credited to the Registrants’ account to be offset against the filing fee for any future registration statement or registration statements.
The Registrant confirms that no securities have been or will be distributed, issued or sold pursuant to the Registration Statement or the prospectus contained therein.
If you have any questions regarding this application for withdrawal, please contact the undersigned at 702-914-7250
Very truly yours,
By
/s/ M ATTHEW S CHISSLER
Matthew Schissler
Chief Executive Officer
the RSI level when it moves up to the 60-80 range for me is when the stock pushes forward.
the technicals says that it's not even in the power zone yet. so i think we will run till EOW and maybe we might get something for christmas as well.
Delta Petroleum Corporation Announces a Settlement on the California Offshore Lease Litigation
DENVER, Dec. 17 /PRNewswire-FirstCall/ -- Delta Petroleum Corporation (Nasdaq: DPTR), an independent oil and gas exploration and development company, announces the signing of a settlement agreement with the federal government concerning Lease 452 located offshore of California.
Delta has signed a settlement agreement with the federal government concerning offshore California Lease 452, which was in litigation. Under the terms of the agreement, Delta will receive gross proceeds of $65 million, which will result in approximately $50 million net to the Company after all contingent payments to third parties. The settlement agreement fully concludes Delta's offshore California litigation against the federal government.
John Wallace, the Company's President and COO said, "We are very pleased to have reached a settlement with the federal government on this final portion of the litigation. The approximately $50 million in net proceeds to Delta substantially increases our liquidity position, and will allow us to evaluate recommencing our drilling program in the near-term or reduce our leverage. Either use of proceeds would benefit our shareholders."
ABOUT DELTA PETROLEUM
Delta Petroleum Corporation is an oil and gas exploration and development company based in Denver, Colorado. The Company's core areas of operations are the Rocky Mountain and Gulf Coast Regions, which comprise the majority of its proved reserves, production and long-term growth prospects. Its common stock is listed on the NASDAQ Global Market System under the symbol "DPTR."
FORWARD-LOOKING STATEMENTS
Forward-looking statements in this announcement are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, estimates of the net proceeds of the settlement and the possible use of such proceeds for drilling activities or debt repayment. Readers are cautioned that all forward-looking statements are based on management's present expectations, estimates and projections, but involve risks and uncertainty, including without limitation, uncertainties in the projection of future rates of production, unanticipated recovery or production problems, unanticipated results from wells being drilled or completed, the effects of delays in completion of gas gathering systems, pipelines and processing facilities, as well as general market conditions, competition and pricing. Please refer to the Company's report on Form 10-K for the year ended December 31, 2008 and subsequent reports on Forms 10-Q and 8-K as filed with the Securities and Exchange Commission for additional information. The Company is under no obligation (and expressly disclaims any obligation) to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
For further information contact the Company at (303) 293-9133 or via email at info@deltapetro.com
DELTA PETROLEUM CORPORATION
Daniel Taylor, Chairman
John Wallace, President and COO
Kevin Nanke, Treasurer and CFO
Broc Richardson, V.P. Corporate Development and IR
370 17th Street, Suite 4300
Denver, Colorado 80202
SOURCE Delta Petroleum Corporation
nice close yest over MA, that's a bullish signal.
just be sure it's not the dude in the background your talking to.
lol
Will Delta Petroleum (DPTR) Be the Next Natural Gas Company for Sale?
December 16, 2009
By Paul Ausick, Contributing Editor, InvestorPlace
Delta Petroleum (DPTR) is probably misnamed. The company's natural gas reserves totaled more than 825 billion cubic feet at the end of 2008, while its crude oil reserves totaled just 9.5 million barrels.
The company ran into problems earlier this year when it reported a dry hole in the Columbia River Basin. That fiasco cost the company more than $50 million that it could not afford. Delta's credit line also took a hit, dropping from $225 million to $185 million. At the end of November, Delta announced that it would seek strategic alternatives, including selling the company. The initial reaction to the news drove the shares down to a new 52-week low of $0.73 just a week ago.
In a sort of delayed reaction to Exxon Mobil's (XOM) agreement to acquire XTO Energy (XTO), Delta's shares began recovering on Tuesday and have been rising ever since. Shares are up again this morning to $1.28, a jump of more than 20% from this morning's open.
Delta's primary holdings are in the Piceance Basin of western Colorado which has been particularly hard hit by the low price of natural gas. Rocky Mountain natural gas trades at a discount to the already low Henry Hub spot price that has been hovering around $5/thousand cubic feet. Rocky Mountain natural gas has been selling for around $3/thousand cubic feet.
There's still another problem. Delta's natural gas reserves are mostly proved, but undeveloped. A buyer, or strategic partner, would most likely have to put up a significant amount of cash to monetize the gas.
At today's market cap of about $365 million, a buyer would be paying less than $0.50/thousand cubic feet of gas. The catch is that development costs could exceed the current selling price of the gas.
So, while it looks like Delta shareholders might be in a good position to see some return on their investment if the company is sold, their optimism might be misplaced. The Exxon purchase of XTO has roiled the waters in the natural gas marketplace, and things won't clear up for a while yet.
http://www.investorplace.com/experts/paul_ausick/articles/delta-petroleum-dptr-next-natural-gas-company-for-sale.html
jumped on board at 1.28 with 2600 shares.
consolidation yesterday and now the trains moving again. hope it's slow and steading with good footing as we go.
and i hope matt movers very strategic with his PR's and timings of them to help with this.
a lab update coming down to thursday friday would be great.
500000 for mew and I'm holding for at least .25 in about a year
good morning folks!!!!
not to sure about beaking therough .0085 today. i really want to see it happen but it seems to be a heavy wall. maybe EOD but tomorrow i see 85 behind us and we will be testing .01
85 printed
64 million volume already. we might get 200+ today. and rsi entering power zone.
84 on the ask now
83 coming soon
fuel the rocket.
good morning folks. great week ahead for CBAI.
i'm long here with 500,000 shares. not looking at the daytrading aspect of cbai at all. so when i speak of price movement a dip here and there is not considered. that charts is excellent for a run up to .01 IMO. if not more.
in the 7'ss slooking for a huge EOD run up.
ask is heading upwards. ma gap up drop a bit to fill the gap and then upppppp. should have nic upward movement till opening.
i see finally google has put up a chart for NEOM.
the charts say that it should be going up. no real pullback here. so load the boat!!
i love waking up to see this
lol
im guessing it's an acronym for Good Luck To All (GLTA)
i was just answering his question as to if it was the same optimus. i provided info as to who our optimus was and the guy behind it.
i don't live in the USA. i'll be there in spirit.
i believe that this is the company is
Optimus CG II, Ltd
ceo being
Terry Peizer
So Terry Peizer is director of Optimus, Terren S. Peizer is CEO of Hythiam. Both companies have the same address
Terren S. Peizer (born 1959) is an American investor and business executive. He is currently Chairman and CEO of Hythiam, Inc., a public company offering the Prometa treatment program for drug and alcohol addiction. Earlier in his career Peizer was a bond salesman with Drexel Burnham Lambert in the 1980s, and helped provide information that led to the conviction of Michael Milken during the government's crackdown on insider trading.
Address:
11150 Santa Monica Boulevard, Suite 1500
Los Angeles, CA 90025
we don't even need to go to nasdaq
look at ADDYY
and many other stocks on the OTC
we can achieve our desired PPS right here.
it's not going to happen overnight
rome was not built in a day, all this speculation and talk is fun but at the end of the day, we are reducing debt, the lab is being fitted, we have a running business, and when january comes around and we launch, that should be the catalyst.
we already have insurance partners
AmeriHealth
AmeriHealth Administrators
Blue Cross Blue Shield of Northeastern Pennsylvania
Highmark Inc.
Independence Administrators
Independence Blue Cross
Keystone, Personal Choice - part of IBC, and BCBS of North Eastern PA
Mountain State Blue Cross Blue Shield
we got the green light for stem cells from government
and
CURRENT STEM CELL APPLICATIONS
Acute Leukemia’s
Acute Lymphoblast Leukemia (ALL)
Acute Myelogenous Leukemia (AML)
Acute Biphenotypic Leukemia
Acute Undifferentiated Leukemia
Chronic Leukemia’s
Chronic Myelogenous Leukemia (CML)
Chronic Lymphocytic Leukemia (CLL)
Juvenile Chronic Myelogenous Leukemia (JCML)
Juvenile Myelomonocytic Leukemia (JMML)
Myelodysplastic Syndromes
Refractory Anemia (RA)
Refractory Anemia with Ringed Sideroblasts (RARS)
Refractory Anemia with Excess Blasts (RAEB)
Refractory Anemia with Excess Blasts in Transformation (RAEB-T)
Chronic Myelomonocytic Leukemia (CMML)
Stem Cell Disorders
Aplastic Anemia (Severe)
Fanconi Anemia
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Pure Red Cell Aplasia
Myeloproliferative Disorders
Acute Myelofibrosis
Agnogenic Myeloid Metaplasia (myelofibrosis)
Polycythemia Vera
Essential Thrombocythemia
Lymphoproliferative Disorders
Non-Hodgkin's Lymphoma
Hodgkin's Disease
Phagocyte Disorders
Chediak-Higashi Syndrome
Chronic Granulomatous Disease
Neutrophil Actin Deficiency
Reticular Dysgenesis
Other Inherited Disorders
Lesch-Nyhan Syndrome
Cartilage-Hair Hypoplasia
Glanzmann Thrombasthenia
Osteopetrosis
Adrenoleukodystrophy
Inherited Platelet Abnormalities
Amegakaryocytosis / Congenital Thrombocytopenia
Inherited Metabolic Disorders
Mucopolysaccharidoses (MPS)
Hurler's Syndrome (MPS-IH)
Scheie Syndrome (MPS-IS)
Hunter's Syndrome (MPS-II)
Sanfilippo Syndrome (MPS-III)
Morquio Syndrome (MPS-IV)
Maroteaux-Lamy Syndrome (MPS-VI)
Sly Syndrome, Beta-Glucuronidase Deficiency (MPS-VII)
Adrenoleukodystrophy
Mucolipidosis II (I-cell Disease)
Krabbe Disease
Gaucher's Disease
Niemann-Pick Disease
Wolman Disease
Metachromatic Leukodystrophy
Histiocytic Disorders
Familial Erythrophagocytic Lymphohistiocytosis
Histiocytosis-X
Hemophagocytosis
Inherited Erythrocyte Abnormalities
Beta Thalassemia Major
Sickle Cell Disease
Inherited Immune System Disorders
Ataxia-Telangiectasia
Kostmann Syndrome
Leukocyte Adhesion Deficiency
DiGeorge Syndrome
Bare Lymphocyte Syndrome
Omenn's Syndrome
Severe Combined Immunodeficiency (SCID)
SCID with Adenosine Deaminase Deficiency
Absence of T & B Cells SCID
Absence of T Cells, Normal B Cell SCID
Common Variable Immunodeficiency
Wiskott-Aldrich Syndrome
X-Linked Lymphoproliferative Disorder
Plasma Cell Disorders
Multiple Myeloma
Plasma Cell Leukemia
Waldenstrom's Macroglobulinemia
Amyloidosis
Other Malignancies
Ewing Sarcoma
Neuroblastoma
Renal Cell Carcinoma
Retinoblastoma
POTENTIAL FUTURE APPLICATIONS
Alzheimer’s Disease
Cerebral Palsy
Cardiac Disease
Diabetes
Epidermolysis Bullosa (rare genetic skin disease)
Lupus
Multiple Sclerosis
Muscular Dystrophy
Parkinson’s Disease
Rheumatoid Arthritis
Spinal Cord Injury
Stroke
lets get this party started!!! still holding onto my 1'sss and i got some more 4'ss