May want to look at this one this week. They will be presenting thier data PhaseII cancer drug 5FU at the ASCO this Friday 13th. This is a where all the biotech company's with Oncology drugs present.
Forbes has an article on it:
http://www.forbes.com/finance/2005/05/09/cz_sg_0509soapbox_inl.html
-
I have recommended this biotech stock before. It's back in play. This is my largest share holding. I am going to retire with this one. I am not promoting the stock because I hate people that do that, but I do have some experience in the biotech industry, and I like what I see in this undiscovered company.
OK, probably not retire, but maybe that Ferrari I have my eye on.
Quote from: saffeysite1 on June 03, 2005, 11:30:37 AM
I have recommended this biotech stock before. It's back in play. This is my largest share holding. I am going to retire with this one. I am not promoting the stock because I hate people that do that, but I do have some experience in the biotech industry, and I like what I see in this undiscovered company.
OK, probably not retire, but maybe that Ferrari I have my eye on.
It looks nice, I'll keep it on my watch list.
bought in and keeping for next week.. nice volume and recommended by saffey? ;) enuf said
what a beautiful chart! A work of art.
I always say, charts don't lie, people do.
Logic always triumphs over emotion in the market.
i think she is setting up pretty, saffey :o
lets see some volume drice it through
there she goes, tomorrow will be interesting saffey
you betcha ya. Nice action today. She's pulling out of the gates.
We are on fire today. This stock is being covered now. I think $5-6 in two months, is very likely.
ADVENTRX Joins the New Russell Microcap Index
Tuesday July 5, 10:00 am ET
SAN DIEGO--(BUSINESS WIRE)--July 5, 2005--ADVENTRX Pharmaceuticals, Inc. (AMEX:ANX - News) today announced that it has been added to the Russell Investment Group's new Russell Microcap(TM) Index. Russell's final membership lists of reconstituted U.S. indexes are available at: http://www.russell.com/us/indexes/us/membership.asp.
The Russell Microcap Index is comprised of the smallest 1,000 securities in the small-cap Russell 2000® Index plus the next 1,000 companies, based on a ranking of all U.S. equities by market capitalization. According to Russell, the Microcap Index was designed to offer managers and other investors a comprehensive, unbiased barometer to compare their performance against the genuine microcap marketplace of stocks.
According to Russell, their indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for both passive and active investment strategies. More than $2.5 trillion in assets currently are benchmarked to them. Investment managers who oversee these funds purchase shares of member stocks according to that company's weighting in the particular index.
Fri Jul 22, 2005 10:40 AM ET
BANGALORE, July 22 (Reuters) - Biopharmaceutical firm Adventrx Pharmaceuticals Inc. (ANX.A: Quote, Profile, Research) on Friday said it had agreed with institutional investors to raise $20 million from a private placement of its common stock.
Icahn and Viking global investors are one of the largest investors in Biotech. This is unexpected great news for ANX.
posting todays chart.
That makes Saffey Happy!
Hope you were in the trade!
Ihave been in since 1.80. I haven't sold any shares. I could made plenty in and out on some of the pr pops, but I am not in it for a couple of bucks. I want to see the $10 day. I feel $5 is near.
I say let your winners run and keep adding to them during pullbacks and sell the losers.
very nice pick.
applaud.
as per your last comment, how do you know when a stock is pulling back as opposed to falling back down?
If I see three big red candles with high sustaining volume = not good for stock. If I get low volume with small red candles staying within the 20/9 ema. I know its pullback, forming a base. Positioning itself for the next leg up.
The best thing I have done is study great charts of stocks that went on to be huge winners throught stock history. THere's a great book by O'neill "Finding winning stocks". It has tons of examples of patterns of stocks that went on to become historic winners.
Hope that answers your question.
Hello Saffey,
Thanks for the O'Neill book recommendation!
As a expert in Biotech, what do you think about PPHM stock?
Regards
I have owned it before and took a loss on it some months ago. MGMT knows how to really burn cash. DOn't know if they raised more capitol for their drug pipline, but look up thier Debt/Cash ratio. IF it's greater than 100. I would Stay out for now.
I have a feeling this is ready to rock anyday...woohoo >:D
I've bough some ANX today, near the closing bell ;)
It's trading inside a short term ascending channel... I'll post here the chart later.
Applaud again saffey ;)
Price and volume. Not much to it. Esp, when the stock is making new highs. %20 retractment.
If a stock is coming off of bottom and starting to begin a new uptrend. Then starts to pull back the next day, Their is no pullback there. I sell.
Study current winning charts. Exp.SWB, FC, TGE, BOOM, GOOGLE.
Let's rock n roll!!!!! ;D
I have the story on this pick......Top Secret....Tell me to buy!!!!! ;)
Ready for tomorrow....... 8)
Ok guys...
Nobody can't argue with me that this chart is ON FIRE !!!!
Because I actually see some fire on it >:D
;D
Okay,I'm in...today.So, let it rip potato chip.
some TA:
ANX released second quarter results this morning:
To me with some familiarity on bio-tech earnings it looks good. Looks like a company going through the motions of bringing its pipeline to the market very efficiently(good job management).
http://biz.yahoo.com/bw/050812/125093.html?.v=1
SAN DIEGO--(BUSINESS WIRE)--Aug. 12, 2005--ADVENTRX Pharmaceuticals, Inc. (AMEX:ANX - News) today announced financial results for the three and six months ended June 30, 2005.
ADVENTRX reported a net loss of $3.3 million, or $0.06 per share, for the second quarter of 2005, compared with a net loss of $1.5 million, or $0.03 per share, for the second quarter of 2004.
"In past several months, we have moved significantly closer to our corporate goal of introducing new anticancer and antiviral treatments that improve the performance and safety of existing drugs," said Evan M. Levine, ADVENTRX president and chief executive officer. "With our lead drug candidate CoFactor(TM), we have reported favorable clinical results that further confirm this drug candidate as a viable replacement for leucovorin to improve 5-fluorouracil (5-FU) effectiveness while lowering toxicity. Additionally, we have initiated a Phase IIb trial and received clearance from the US Food and Drug Administration (FDA) to begin a pivotal Phase III trial with CoFactor in metastatic colorectal cancer patients. Further, our preclinical work with Thiovir(TM) indicates that this orally administered, broad spectrum antiviral drug candidate shows potential promise as a more convenient, less toxic alternative to foscarnet for the treatment of opportunistic infections in HIV patients.
"With the completion of our $20 million financing, we are well situated financially to move forward with our aggressive clinical development plans with CoFactor and further capitalize on our drug development pipeline opportunities," added Mr. Levine.
Second Quarter and First Half of 2005 Financial Review
Research and development expenses for the second quarter of 2005 were $2.2 million, versus $773,000 for the second quarter of 2004. The increase for the 2005 second quarter was related primarily to expenses associated with the Company's clinical trials with CoFactor. General and administrative expenses for the 2005 second quarter were $1.1 million, compared with $746,000 for the same period in 2004. This increase was due primarily to the hiring of additional personnel in the finance and marketing, and business development departments; increased directors and officers insurance premiums; increased legal fees; and increased expenses associated with business development activities.
For the six months ended June 30, 2005, net loss was $6.2 million, or $0.11 per share, compared with a net loss of $2.2 million, or $0.05 per share, for the same period in 2004.
For the first six months of 2005, research and development expenses were $3.9 million, compared with $1.1 million first six months of 2004. General and administrative expenses for the first half of 2005 were $2.3 million, compared with $1.2 million for the same period in 2004.
The Company reported that it expects research and development expenses to significantly increase from levels reported in the 2005 second quarter as it ramps up for a pivotal Phase III CoFactor clinical trial and continues patient enrollment in its Phase IIb CoFactor clinical trial. The timing of the increase in research and development expenses is directly related to the timing of the launch of the Phase III trial, and the amount of increase will be directly related to the success and speed in patient enrollment in these trials. The Company also expects that general and administrative expenses will increase measurably during the remainder of 2005 as it prepares for compliance with Section 404 of the Sarbanes-Oxley Act.
ADVENTRX reported cash and cash equivalents of approximately $8.1 million as of June 30, 2005, compared with $13.0 million as of December 31, 2004. In July, the Company announced the completion of a $20 million private placement of the Company's common stock and warrants. Funds from this transaction will be reflected on the Company's balance sheet in the third quarter ending September 30, 2005.
About ADVENTRX
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing new technologies for anticancer and antiviral treatments that improve the performance and safety of existing drugs by addressing significant problems such as drug metabolism, toxicity, bioavailability and resistance. The Company's lead compound, CoFactor, is a biomodulator of 5-FU, a widely used cancer chemotherapy. CoFactor met the primary endpoint for response and secondary endpoint for safety in an ongoing Phase II clinical trial. CoFactor is currently being tested with 5-FU in this US-based Phase II clinical trial and an EU-based Phase IIb clinical trial as a first line treatment of metastatic colorectal cancer. In addition, CoFactor has received clearance under a special protocol assessment from the US FDA to begin a Phase III pivotal clinical trial for metastatic colorectal cancer. More information can be found on the Company's Web site at www.adventrx.com.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements are made based on management's current expectations and beliefs. Actual results may vary from those currently anticipated based upon a number of factors, including uncertainties inherent in the drug development process, the timing and success of clinical trials, the validity of research results, and the receipt of necessary approvals from the FDA and other regulatory agencies. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's last quarterly report on Form 10-Q, as well as other reports that the Company files from time to time with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement. The Company undertakes no obligation to release publicly any revisions, which may be made to reflect events or circumstances after the date hereof.
ADVENTRX PHARMACEUTICALS, INC. AND SUBSIDIARY
(A Development Stage Enterprise)
Condensed Consolidated Statements of Operations
(unaudited)
Three months ended Six months ended
June 30, June 30,
------------------------ ------------------------
2005 2004 2005 2004
----------- ----------- ----------- -----------
Net sales $ -- $ -- $ -- $ --
Cost of goods sold -- -- -- --
----------- ----------- ----------- -----------
Gross margin -- -- -- --
Grant revenue -- -- -- --
Interest income 64,597 13,341 101,919 16,687
----------- ----------- ----------- -----------
64,597 13,341 101,919 16,687
----------- ----------- ----------- -----------
Operating expenses:
Research and
development 2,236,609 773,091 3,941,406 1,069,466
General and
administrative 1,123,577 745,838 2,273,910 1,160,220
Depreciation and
amortization 34,965 3,666 62,091 6,718
Impairment loss -
write off of
goodwill -- -- -- --
Interest expense -- -- -- --
Equity in loss of
investee -- -- -- --
----------- ----------- ----------- -----------
Total operating
expenses 3,395,151 1,522,595 6,277,407 2,236,404
----------- ----------- ----------- -----------
Loss before
cumulative effect
of change in
accounting
principle (3,330,554) (1,509,254) (6,175,488) (2,219,717)
Cumulative effect
of change in
accounting
principle -- -- -- --
----------- ----------- ----------- -----------
Net loss (3,330,554) (1,509,254) (6,175,488) (2,219,717)
Preferred stock
dividends -- -- -- --
----------- ----------- ----------- -----------
Net loss
applicable to
common stock $(3,330,554) $(1,509,254) $(6,175,488) $(2,219,717)
=========== =========== =========== ===========
Loss per common
share - basic
and diluted $ (.06) $ (.03) $ (.11) $ (.05)
=========== =========== =========== ===========
ADVENTRX PHARMACEUTICALS, INC. AND SUBSIDIARY
(A Development Stage Enterprise)
Condensed Consolidated Balance Sheets
June 30, December 31,
2005 2004
------------- --------------
(unaudited)
Assets
Current assets:
Cash and cash equivalents $ 8,102,824 $ 13,032,263
Accrued interest income -- 10,808
Prepaid expenses 471,335 115,144
Other current assets 3,138 --
Assets available for sale -- 108,000
------------- --------------
Total current assets 8,577,297 13,266,215
------------- --------------
Property and equipment, net 342,036 285,304
Other assets 58,387 57,268
------------- --------------
Total assets $ 8,977,720 $ 13,608,787
============= ==============
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 270,779 $ 532,327
Accrued liabilities 770,612 628,753
Accrued salary and related taxes 126,364 57,315
------------- --------------
Total current liabilities 1,167,755 1,218,396
Commitments and contingencies -- --
Shareholders' equity:
Common stock, $0.001 par value.
Authorized 100,000,000 shares; issued
55,046,086 shares in 2005 and
53,834,237 shares in 2004 55,047 53,835
Additional paid-in capital 49,147,347 47,553,497
Deficit accumulated during the
development stage (41,357,682) (35,182,194)
Treasury stock, 23,165 shares at cost (34,747) (34,747)
------------- --------------
Total shareholders' equity 7,809,965 12,390,391
------------- --------------
Total liabilities and
shareholders' equity $ 8,977,720 $ 13,608,787
============= ==============
Contact:
ADVENTRX Pharmaceuticals
Andrea Lynn, 858-552-0866
or
Investor Contact:
Lippert/Heilshorn & Associates
Jody Cain (
[email protected])
Brandi Floberg (
[email protected])
310-691-7100
Source: ADVENTRX Pharmaceuticals, Inc.
Is everyone still bullish on ANX?
Looking to start postion and would welcome any input.
I would like to see 3.30 hold but 3.19 is also there. Here is a support study I am doing. Market is down heavy today.. so ANX is just doing what most other stocks are doing. The bullish side of things are still there. I will give it till Monday at least :)
I'm in at 3.48 with stop at 3.17
Down to 3.35 right now on an average looking volume day.
I think the 'earnings crowd may have cut bait - JMO
thx elite and kc. I am holding this baby for atleast three more days. There will be some shakeout and I am staying.
$3.50 at close. Sleep tight everyone and see ya on Monday.
3SOF......SOLD This moments ago!!!!!
I'm selling also.I will follow 3SOF on this sell.
Quote from: setravis on September 07, 2005, 01:46:24 PM
3SOF......SOLD This moments ago!!!!!
I'm selling also.I will follow 3SOF on this sell.
Hi Setravis,
I really enjoy ANX... And I believe it will be a mid-term winner, but I had to follow my plan, and sold to the 3 stocks portfolio @ 3.80 ;)
regards,
Hello,
Perhaps a good one to keep it on the radar ;)
rafael
(ANX)........
ANNOUNCES POSITIVE RESULTS FROM CLINICAL STUDY: ADVENTRX Pharmaceuticals,
Inc. (ANX) announced positive results from its marketing-enabling clinical study of ANX-530
(vinorelbine emulsion). Pharmacokinetic equivalence, the primary endpoint of the study, was
observed between ANX-530 and Navelbine(R), the reference product, in patients with advanced
cancer potentially sensitive to vinorelbine. The Company anticipates safety and full clinical results
will be available during the first quarter of 2008. ANX-530 is a novel emulsion formulation
of vinorelbine. Vinorelbine, marketed under the brand name Navelbine(R), also available as
generic vinorelbine, is an anti-cancer agent approved to treat advanced non-small cell lung cancer
as a single agent or in combination with cisplatin. Worldwide annual sales of Navelbine and
generic vinorelbine in 2006 were approximately $200 million.
SAN DIEGO, Feb 10, 2009 /PRNewswire-FirstCall via COMTEX/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Alternext US: ANX) announced today that it has received written indications of interest from numerous companies representing a range of strategic transactions. The Company currently is evaluating all proposals and options. In December 2008, the Company announced that it was exploring a range of strategic options, including the sale or disposition of one or more of its product candidate programs, a strategic business merger and other transactions that maximize the value of the Company's assets.
"We are pleased with the number and breadth of opportunities presented to us and are currently negotiating with interested parties," stated Brian M. Culley, Chief Business Officer of ADVENTRX. "In order to provide sufficient flexibility to consummate a transaction on appropriate terms, we continue to curtail our spending. While this may impact the timelines of our regulatory filings, it is likely that a future partner would make the final decision on the timing of each NDA submission. However, we still remain on track to announce pharmacokinetic data from our bioequivalence study of ANX-514 in the second quarter."
About ANX-514 (docetaxel emulsion)
ANX-514 is a novel nano-emulsion formulation of the chemotherapy drug docetaxel, a formulation of which is marketed under the brand name Taxotere(R). ANX-514 is formulated without polysorbate 80 or other detergents and is intended to reduce the severity and incidence of hypersensitivity reactions. Docetaxel is an anti-cancer agent that acts by disrupting the cellular microtubular network that is essential for cell division. Immunosuppressant premedication is recommended for docetaxel therapy to reduce the incidence and severity of hypersensitivity reactions. Docetaxel is approved to treat breast, non-small cell lung, prostate, gastric and head and neck cancers.
About ANX-530 (vinorelbine emulsion)
ANX-530 is a novel emulsion formulation of the chemotherapy drug vinorelbine. ANX-530 emulsifies vinorelbine into a homogeneous suspension of nanoparticles that is designed to protect the venous endothelium during administration into a peripheral vein. Navelbine(R), a branded formulation of vinorelbine, is approved in the U.S. to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin, and approved in the European Union to treat non-small cell lung cancer and advanced or metastatic breast cancer.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical company focused on in- licensing, developing and commercializing proprietary product candidates primarily for the treatment of cancer. The Company seeks to improve the performance and commercial potential of existing treatments by addressing problems associated with these treatment regimens. In December 2008, the Company announced that it is exploring a range of strategic options, including the sale or disposition of one or more of its product candidate programs, a strategic business merger and other transactions that maximize the value of the Company's assets. More information can be found on ADVENTRX's web site at http://www.adventrx.com.
Forward Looking Statements
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks and assumptions that, if they materialize or do not prove to be accurate, could cause ADVENTRX's results to differ materially from historical results or those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that ADVENTRX will be unable to consummate a strategic or partnering transaction or raise sufficient capital to fund the projects necessary to meet its goals, including funding the continued development and commercialization of ANX-530 or ANX-514; the risk that the Company's recent cost-containment measures, as well as any future workforce reductions and/or reductions/delays in spending, will further impact the Company's development and commercialization plans, including its ability to achieve on time its previously stated goals; the risk that the departure of the Company's former Chief Executive Officer and President and Executive Vice President and Chief Financial Officer and/or ADVENTRX's leadership by a committee of executive officers will negatively impact ADVENTRX's ability to execute its business plan or to maintain effective disclosure controls and procedures or internal control over financial reporting; the risk the FDA will determine that ANX-530 and Navelbine are not bioequivalent, including as a result of performing pharmacokinetic equivalence analysis based a patient population other than the population on which ADVENTRX based its analysis; the risk that the bioequivalence study of ANX-514 does not demonstrate pharmacokinetic equivalence or bioequivalence to Taxotere; the risk of investigator bias in reporting adverse events as a result of the open-label nature of the ANX-530 bioequivalence study, including bias that increased the reporting of adverse events associated with Navelbine and/or that decreased the reporting of adverse events associated with ANX-530; difficulties or delays in manufacturing, obtaining regulatory approval for and marketing ANX-530 and ANX- 514, including validating commercial manufacturers and suppliers and the potential for automatic injunctions regarding FDA approval of ANX-514; the potential for regulatory authorities to require additional preclinical work or other clinical requirements to support regulatory filings, including prior to the submission or the approval of an NDA for ANX-530 and ANX-514; the risk that the performance of third parties on whom ADVENTRX relies to conduct its studies or evaluate the data, including clinical investigators, expert data monitoring committees, contract laboratories and contract research organizations, may be substandard, or they may fail to perform as expected; the risk that ADVENTRX's stockholders will not approve a strategic or capital-raising transaction recommended by ADVENTRX's Board of Directors; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX's public filings with the Securities and Exchange Commission are available at http://www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date on which it was made.
SOURCE ADVENTRX Pharmaceuticals, Inc.
http://www.adventrx.com/
Copyright (C) 2009 PR Newswire. All rights reserved
market pulse
Jan. 6, 2011, 11:11 a.m. EST
Adventrx climbs on FDA update
BOSTON (MarketWatch) -- Shares of Adventrx Pharmaceuticals /quotes/comstock/14*!anx/quotes/nls/anx (ANX 2.96, +0.03, +1.02%) advanced in early trading Thursday on news that the U.S. Food and Drug Administration has accepted the market application for its drug Exelbine, or vinorelbine injectable emulsion. The product is an new formulation of the chemotherapy agent vinorelbine, also known as Navelbine, which is used for the treatment of lung cancer. Adventrx shares were up 14% at $3.04.
Below the 3 year chart...
Day's Range: 2.92 - 3.45
52wk Range: 1.50 - 13.00
Volume: 6,371,770
Avg Vol (3m): 447,753
Market Cap: 43.07M
P/E (ttm): N/A
EPS (ttm): -1.65
Div & Yield: N/A (N/A)
Technicals
Close Above the 13-day EMA
Most Actives
Gap Up
Percentage Gainer
Last Price Quote is:
9.16%above 13-day EMA
21.21%above 50-day EMA
RS Rating: 89
FDA Accepts Exelbine NDA for Filing
Press Release Source: ADVENTRX Pharmaceuticals, Inc. On Thursday January 6, 2011, 8:00 am EST
SAN DIEGO, Jan. 6, 2011 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for its product candidate ANX-530 (vinorelbine injectable emulsion), or Exelbine. The filing of the Exelbine NDA means the FDA has made a threshold determination that it is sufficiently complete to permit a substantive review.
"We are pleased to have reached this important milestone, and look forward to working with the FDA on moving Exelbine toward approval in 2011," said Brian M. Culley, Chief Executive Officer of ADVENTRX.
About Exelbine
ADVENTRX is seeking approval of Exelbine for the same indications as Navelbine®, a branded formulation of vinorelbine, including non-small cell lung cancer. ADVENTRX submitted the NDA as a 505(b)(2) application that relies in part on the FDA's findings of safety and effectiveness of a reference drug. The Exelbine NDA includes data from one clinical bioequivalence study designed to assess the pharmacokinetic equivalence of Exelbine and Navelbine, the reference drug. In this clinical bioequivalence study, Exelbine and the reference drug were determined by ADVENTRX to be bioequivalent.
ADVENTRX retains exclusive worldwide rights to Exelbine, other than in South Korea, China, Hong Kong, Macau and Taiwan. In March 2010, the FDA conditionally accepted "Exelbine" as the proposed proprietary name for ANX-530. The United States Patent and Trademark Office has allowed patent claims related to Exelbine, which claims will issue in January 2011 and expire in November 2027.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a specialty pharmaceutical company whose product candidates are being developed to improve the performance of existing anti-cancer drugs by addressing limitations associated principally with their safety and use. More information can be found on the Company's web site at www.adventrx.com.
Forward Looking Statements
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that are based on ADVENTRX's current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements regarding regulatory approval of Exelbine based on the 505(b)(2) NDA accepted for filing, working with the FDA in the regulatory review process and the bioequivalence of Exelbine and Navelbine. Actual events or results may differ materially from those expressed or implied by the forward-looking statements in this press release due to a number of risks and uncertainties, including, without limitation: the risk that ADVENTRX does not receive FDA approval of Exelbine on a timely basis, or at all; the potential for the FDA to determine that the bioequivalence data and other information included in the Exelbine NDA does not adequately support bioequivalence with Navelbine, including as a result of performing pharmacokinetic equivalence analyses based on a patient population other than the population on which ADVENTRX based its analysis; the potential that changes made in transferring the manufacturing process for Exelbine may result in a lack of comparability between the commercial product and the material used in the bioequivalence trial; the risk that results of future stability testing on samples of Exelbine do not support comparability between ADVENTRX's prior and intended commercial manufacturing sites or a commercially-viable expiration dating period; the potential for the FDA to impose other requirements to be completed before or after approval of the Exelbine NDA, including that the FDA may require ADVENTRX to perform additional nonclinical, bioequivalence or clinical studies; ADVENTRX's reliance on third parties to assist with its bioequivalence trials, regulatory submissions, manufacturing and other important aspects of the Exelbine development program, and the risk that FDA approval may be delayed if their performance is found to have been substandard; the risk that any patent issued to ADVENTRX may not provide sufficient protection and market exclusivity for Exelbine and may be challenged, invalidated, infringed or circumvented by third parties, including by ADVENTRX's competitors; ADVENTRX's dependence on the success of Exelbine as its first product candidate to be submitted for regulatory approval; the potential that ADVENTRX may require substantial additional funding in order to obtain FDA approval for and commercialize Exelbine, and the risk that ADVENTRX may not be able to raise sufficient capital when needed, or at all; the potential for ADVENTRX to enter into a commercial partnership or other strategic transaction relating to Exelbine and that such partnership or transaction may not succeed in commercializing Exelbine; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX's public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date hereof, except as may be required by law.