ANX - ADVENTRX Pharmaceuticals Inc. Sets Meeting With FDA to Discuss ANX-530 NDA:

ADVENTRX Sets Meeting With FDA to Discuss ANX-530 NDA:

Press Release Source: ADVENTRX Pharmaceuticals, Inc. On Friday March 26, 2010, 8:30 am EDT
SAN DIEGO, March 26 /PRNewswire-FirstCall/

ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that it will meet the U.S. Food and Drug Administration (FDA) in Washington D.C. during the last week of April 2010 to review the Company's New Drug Application (NDA) for ANX-530 (vinorelbine injectable emulsion) and the FDA's refusal-to-file letter.

ADVENTRX had requested a face-to-face meeting with the FDA to understand its requirements and define the path to a successful filing of an ANX-530 NDA at the earliest possible time.

"We look forward to meeting with the agency next month to clarify the necessary steps for filing the ANX-530 NDA this year," said Brian M. Culley, Chief Executive Officer of ADVENTRX.

ADVENTRX submitted an NDA for ANX-530 to the FDA in December 2009. The Company announced on March 1, 2010 that it had received a refusal-to-file letter from the FDA regarding that submission. In the letter, the FDA indicated that the data included in the December 2009 NDA submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period. The FDA identified only this one chemistry, manufacturing and controls (CMC) reason for the refusal to file. No clinical or nonclinical issues were identified.

About ADVENTRX Pharmaceuticals:

ADVENTRX Pharmaceuticals is a specialty pharmaceutical company whose product candidates are designed to improve the performance of existing cancer treatments 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

http://finance.yahoo.com/news/ADVENTRX-Sets-Meeting-With-prnews-3495683683.html?x=0&.v=1

Stocks to Watch on Monday March 22nd, 2010: ANX - HDY - RNN - GSL - IDT - POL - FORD - GENT

Three AMEX Stocks: ANX - HDY - RNN:

ANX - There may be some news released next week, giving a date for the the face-to-face meeting with the FDA about the Refuse to File Letter on the NDA for their drug ANX-530.



HDY - It closed above the 15 Moving Average on above average Volume on Friday. All of the technical indicators are showing upticks, and look much more Bullish than they have in the past.



RNN - May be starting another run here. Look at what happened the last time the CCI crossed up through the +100 line. Volume picked up on Friday, and most of the technical indicators are showing improvement.



Three NYSE Stocks:

GSL - Has broken above a previous level of Resistance on above average Volume. Most of the technical indicators are showing signs of improvement.



IDT - It may be a bit too late to catch this Runaway Train, but Volume keeps increasing as it rallies, and all of the technical indicators look very Bullish.



POL - Had a HUGE pop up on Friday with over five times average daily Volume. Every one of the technical indicators are very Bullish.



Two NASDAQ Stocks:

FORD - Has broken above all levels of Resistance on above average Volume, and every technical indicator is upticking very sharply and are looking Bullish.



GENT - Also broke above all levels of Resistance on Friday on very high volume. All of the technical indicators are looking Bullish at this time, except the Accumulation/Distribution line (black). That was most likely due to massive profit taking on the huge pop up it did.



Happy Trading next week,
zigzagman

ADVENTRX Receives Brand Name Acceptance for ANX-530:

ADVENTRX Receives Brand Name Acceptance for ANX-530:

SAN DIEGO, March 12 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that the U.S. Food and Drug Administration (FDA) has accepted the proposed proprietary name "Exelbine™" for the Company's product candidate ANX-530 (vinorelbine injectable emulsion).

"We are pleased with the FDA's response to our proprietary name request and look forward to continued regulatory progress on ANX-530," said Brian M. Culley, Chief Executive Officer of ADVENTRX.

Following completion of its review process, the FDA concluded that "Exelbine" is acceptable provided the information presented by ADVENTRX regarding the safety of interchanging ANX-530 with other vinorelbine injectable products is confirmed during review of an ANX-530 New Drug Application (NDA).

As previously announced, the Company submitted an NDA for ANX-530 to the FDA in December 2009. In March 2010, the Company announced that it had received a refusal-to-file letter from the FDA regarding its ANX-530 NDA submission. In the letter, the FDA indicated that the data included in the December 2009 NDA submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period. The FDA identified only this one chemistry, manufacturing and controls (CMC) reason for the refusal to file. ADVENTRX has requested a face-to-face meeting with the FDA to understand its requirements and define the path to a successful filing of an ANX-530 NDA at the earliest possible time.

About ADVENTRX Pharmaceuticals:

ADVENTRX Pharmaceuticals is a specialty pharmaceutical company whose product candidates are designed to improve the performance of existing cancer treatments 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.

http://www.prnewswire.com/news-releases/adventrx-receives-brand-name-acceptance-for-anx-530-87453562.html

ANX closed at $0.21 yesterday, and hit $0.29 in the pre-market session this morning:

ANX - ADVENTRX Pharmaceuticals Receives Refusal to File Letter from FDA on ANX-530 New Drug Application:

ADVENTRX Receives Refuse to File Letter from FDA on ANX-530 New Drug Application:

http://finance.yahoo.com/news/ADVENTRX-Receives-Refuse-to-prnews-815147953.html?x=0&.v=1

Press Release Source: ADVENTRX Pharmaceuticals, Inc.
On Monday March 1, 2010, 1:00 am

SAN DIEGO, March 1 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it received a refuse to file letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ANX-530 (vinorelbine injectable emulsion). In the letter, the FDA indicated that the data included in the initial submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period. FDA identified only the one chemistry, manufacturing and controls (CMC) reason for the refusal to file. ADVENTRX plans to meet with the FDA as soon as possible to discuss its response.

To support a commercially-viable expiration dating period, the stability data provided in the ANX-530 NDA met ICH filing requirements for a new drug. Site-specific stability data from lots manufactured at the intended commercial manufacturing site also were submitted in the NDA.

"We believed, following discussions with the FDA at a pre-NDA meeting, the stability data package included in our initial submission supported both NDA acceptance and appropriate expiration dating. However, we now expect FDA will require additional site-specific stability data to accept our application. Although we plan to discuss the particular filing requirements with the reviewing chemists, site-specific stability studies are already ongoing and our recent financings provide us the capital to continue this work and, we expect, resubmit the application," said Brian M. Culley, Chief Executive Officer at ADVENTRX.

"We will work closely with the Agency to understand its new requirements and define the path to a successful resubmission at the earliest possible time," Mr. Culley continued.

ADVENTRX submitted the NDA for ANX-530 on December 30, 2009. Based on current regulations, once an NDA is submitted to the FDA, FDA has 60 days to preliminarily review the NDA submission and assess whether the NDA is sufficiently complete to permit a substantive review. If it determines that the NDA is not sufficiently complete, the FDA issues a refuse to file letter to the applicant. ADVENTRX plans to request a meeting with the FDA as soon as possible to discuss its comments on the NDA submission and to reach an understanding on what would be required for the ANX-530 NDA to be accepted for review.

Conference Call and Webcast

ADVENTRX will hold a conference call on Monday, March 1, 2010 beginning at 9:00 a.m. Eastern time to review the developments discussed in this news release. Individuals interested in listening to the conference call may do so by dialing (866) 305-6438 for domestic callers, or (706) 679-7161 for international callers, or from the webcast on the investor relations section of the Company's Web site at www.adventrx.com. A 48-hour telephone replay will be available approximately one hour after the conclusion of the call by dialing (800) 642-1687 for domestic callers, or (706) 645-9291 for international callers, and entering reservation code 60223016. The webcast will be available on the Company's Web site for 14 days following the completion of the call.

This news comes as a complete surprise. It looks like management really dropped the ball on this NDA application, and appears at this point to be totally incompetent. They had meetings with the FDA before submitting the NDA, and should have been aware of exactly what kind of information the FDA wanted them to submit for the application to get approval.

ANX - ADVENTRX Pharmaceuticals Is Expecting FDA News This Week:

ANX submitted a NDA (new drug application) to the FDA during the last week of December 2009, and the FDA has sixty days to give the company it's decision if it will accept the application or issue a RTF Letter (refusal to file letter). That means that the company most likely has already received the FDA's decision, and they have 72 hours after receiving the decision to issue a Press Release about the decision. There should be a PR about this released during the week of March 1st to March 5th 2010.

There has been a lot of talk this weekend if the FDA accepts the NDA for ANX-530 will it be eligible for either Fast Track or Priority Status, which would reduce the number of months until it's PDUFA date. A normal time frame for a PDUFD date to be set is ten months from the date the NDA was submitted. Since the NDA was submitted during the last week of December 2009, the Normal Review PDUFA date would be set for the last week of October 2010. Receiving an accelerated review with either a Fast Track or Priority Review Status would reduce the PDUFA date by a number of months depending on which accelerated status it receives.

In order for a NDA to be classified with an accelerated status the company must request it when they submit the NDA. We have no idea if ANX requested a Fast Track or a Priority Review when they submitted the NDA application.

There are a lot of traders on the many message boards I am a member of, and blogs that I read that think the share price of ANX will skyrocket up once we get the PR that the FDA has accepted the NDA for ANX-530. In all of the years I've been following FDA plays, I've rarely seen a huge move up on just the news that a NDA was accepted.

There may be a nice move up on the day the FDA news is PR'd due to retail buying and maybe a little bit of Short Covering. But as soon as buying volume drys up I have a feeling the Shorts will be adding to their positions again in an attempt to hold this stock down like they've been able to do most of this year.

The only times I've seen a large and sustainable increase in the share price is if the FDA assigns either Fast Track or Priority Status. When that happens, the market really takes notice and the share price soon reflects it.

If the FDA accepts the application that would be very good news for this company because the FDA is not only ruling if the drug ANX-530 is worthy of further review, but more importantly that their proprietary emulsion process also has merit. Every new drug this company has in it's pipeline and plans to submit to the FDA for approval is based on this unique and patentable emulsion technology.

During the past two months, there has been a lot of talk about a buyout, takeover, or partnership of ANX by either GlaxoSmithKline (NYSE-GSK) or Sanofi-Aventis (NYSE-SNY). The reason one or both of these huge drug manufacturing companies would be interested in in taking ANX over is because they both stand to lose a lot of potential market share if ANX's drugs go to market in competition with their existing drugs.

ANX-530 would be in direct competition with GSK's drug Vinorelbine, which has a worldwide annual market estimated at around $200 million. ANX-514 would be in direct competition with SNY's drug Taxotere, which has a worldwide annual market share estimated at around $3 BILLION! Not only would they be removing competition from their existing drugs, but they would also become owners of the proprietary emulsion technology that could be applied to many other existing drugs to make them safer and more effective.

Usually, when a buyout offer is tendered, the offer price is between 300-500% above the current share price. ANX is currently trading at around $0.30 per share so a 300% increase would put the buyout offer at $0.90 and a 500% increase would put the buyout offer at $1.50 The traders that are calling for a buyout offer between $3.00 to $4.00 are dreaming in my opinion.

There are many traders that entered Long positions hoping for buyout to happen, because they have done their research on this company and know it is a definite possibility. If they hold a sizeable position between $0.15 to $0.50 they stand to make a nice profit if a buyout offer is tendered.

I am one of those traders, but I didn't enter my position just because of the possibility of a buyout. I have looked into this company's history, and there has been a lot of good changes made since the previous CEO ran the company. But the bottom line is I think that their technology is fantastic, and it will be able to make many existing drugs much more effective and safer.

Here is a three month/daily chart of ANX. It ran from below $0.10 to $0.52 in the past few months, and it has held half of it's gains which shows a lot of strength and is considered Bullish. Keep this stock on your radar next week, because if the PR comes out saying that the NDA for ANX-530 has been accepted there should be a nice move to the upside. If the FDA assigns an accelerated review process designation, there may be a very large and sustainable move of the share price to the upside. In My Honest Opinion.

Happy Trading,
zigzagman

VIDEO: Technical Analysis of ANX - ADVENTRX Pharmaceuticals Daily & Weekly Charts - Feb. 21, 2010:

This is the third weekend I've done the end of the week Fundamental and Technical Analysis of ANX's daily and weekly charts...

We are expecting news in the very near future that will tell us if the FDA has accepted the NDA (new drug application) for their drug candidate ANX-530

Things are about to get VERY interesting with this stock in the next week or two...Stay tuned for recent developments as they happen...

Disclaimer: I hold a lot of shares of ANX, and am VERY Bullish on this company...GLTA

Happy Trading,
zigzagman

VIDEO: Technical Analysis of ANX's Daily & Weekly Charts - Feb. 15, 2010:

We only have to wait two weeks or less before we hear if the NDA for ANX-530 will be accepted by the FDA...That news WILL determine the next move for this stock...Either up or down...Volume should pick up again once this news is released...

This video is viewed best at 480p and full-screen mode...Start the video, click on 480p in the lower right corner, then click the four arrows pointing different direction to go to full-screen mode...Press the Escape key on your keyboard to exit full-screen mode...

Happy Trading,
zigzagman

Video: Technical Analysis of ADVENTRX Pharmaceuticals Daily Chart:

Here is an analysis of ANX's daily chart. It was created yesterday around lunch time, and this was the first day of trading after ANX's CEO Brian Culley gave his presentation at the Bio CEO & Investors Conference.

ANX closed down two cents yesterday. I won't draw any conclusions about that yet, because it will take a few days before potential large and institutional investors decide if they will invest in this company or not.

One reason for the drop in share price yesterday is probably because the day traders bailed out when no new and earth moving news was released at the conference. Many people probably took positions in this stock hoping that there would be a big pop up in the share price right after the presentation. When that didn't happen, they moved on to greener pastures.

It's starting to look like the share price may not move much for the next two to three weeks as we await news from the FDA if the new drug application for ANX-530 will be accepted or not.



Here is an interesting reply to a post I made on the Yahoo Finance message board for ANX, that clarifies a few things very well. This member has my respect, since he works in the field of biotechnology research and knows quite a bit about the process of bringing new drugs to market through FDA aprroval:

==============================================================

"Gentlemen, I appreciate the attempt at substantive conversation about ANX and its product candidates. I will not comment on the potential stock price both prior to and after the ACCEPTANCE (not approval) of the NDA filing. What I would like to do is clear up some misunderstandings expressed in these two posts.

First, what we are awaiting in March is the acceptance of the filing. This is a confirmation that the NDA was properly FORMATTED and prepared according to protocol. This does not reflect in any way on the merits of the application (ie:chances for approval). If there are filing inadequacies, they will be noted and subsequently corrected by the company. That is the only delay possible. The agency will not/cannot request additional trials, as this would amount to a judgement on the merits of the application which will not be done until 10 months from the filing date.

To be clear: there is NO POSSIBILITY for priority review or fast rack status. This drug does not represent the treatment of unmet medical need as per FDA guidelines. Please don't debate this just look it up if you have questions. 10 months will be the review time.

Next. You made some reference to news re: 514 about an NDA filing. The guidance on this program was given yesterday, and quite clearly to those that listened to the presentation.

Anx must prepare a package laying out its arguments as to why the increase in the plasma concentration of docetaxol during the first 3 hours of administration of 514 is not relevant to prevent a finding of bioequivilence. After the filing of this package, the FDA has 60 days to set up a meeting. AFTER this meeting, the company will announce future plans for 514. Hence no surprise announcements, until May at the earliest.

And again, just for terminology and expectations, the FDA will not "approve" 530 in two weeks. The will hopefully accept the filing of the application for approval in October.

I know there are well meaning longs on this board, but it really would help to have all of the facts and not create expectations on erroneous premises.

As I have said many times here, I am long a large number of shares and am looking forward to the setting of the PDUFA date for October for 530. But I don't personally see the properly formatted application being a huge share price event. I frankly expect it as anyone who is long this stock should. It will not be a surprise.

514 in May is the news that blows the lid off of this stock. Is 3 months really that long to wait for an "investor?"

Not this one. GLTA

Laser

Sentiment : Strong Buy"

==============================================================

Happy Trading!,
zigzagman

re: ANX's Presentation at the Bio CEO & Investors Conference:

After watching ANX's presentation a couple of times yesterday, these are my impressions.

First, CEO Culley said that they should hear from the FDA about their decision to accept or deny the NDA for ANX-530 "in the next two weeks or so". This is something we all knew already, because the NDA was submitted in the final days of December 2009. The FDA has 60 days to make it's decision to accept, ask for more data (which means a long delay), or outright reject the NDA.

That gives the FDA until the last week of February or the first week of March to give ANX their decision on the NDA. I've been following small cap and micro cap biotech companies for about two years, and in all that time I've never seen the FDA render a decision early. So the best we can hope for is for the company to get their decision around the first of March, and to release a Press Release soon thereafter.

Yesterday's presentation was nearly a carbon copy of the presentation they made at the OneMedForum conference in San Francisco on December 15th 2009. The slide show was exactly the same, and the CEO's speech was almost identical. There were no new developments mentioned that we weren't already aware of. It was a very good presentation though, and I really like Mr. Culley's enthusiasm and speaking style.

The purpose of these types of conferences is to inform investors of what the company is all about, and to hopefully get them to invest in the company. I hope that Mr. Culley was successful in doing just that.

If you would like to listen to the presentation, here is a link to go to the webcast:

http://ir.adventrx.com/phoenix.zhtml?c=75414&p=irol-IRHome

Here is a post I made last night on the ANX Board at the InvestorsHub.com (IHUB) site:

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=46474923

It is an analysis of ANX's daily chart using a number of Technical Indicators.

Happy Trading!,
zigzagman

ADVENTRX Pharmaceuticals Inc. Presents At The 12th Annual Bio CEO & Investors Conference Today:

ANX is one of my favorite small cap BioTech stocks at the moment.

It is listed on the AMEX exchange, and is currently trading at around $0.30 per share. It has been a Volume Leader on the AMEX for two months or so. Here is a link to the company's website:

http://www.adventrx.com/

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.

ADVENTRX is presenting at the 12th Annual Biotechnology Industry Organization CEO & Investor Conference. Here is a list of all of the companies presenting at the conference. I have been following many of them for over a year:

http://ceo.bio.org/opencms/ceo/2010/Companies/PresentingCompanies.html

Here is the link to listen to the webcast live at 10:30am ET, or you can listen to it later:

http://ir.adventrx.com/phoenix.zhtml?c=75414&p=irol-IRHome

I don't expect any new news to be presented at this conference, because SEC Regulations require that a press release of any material event must be published to the entire world and not just to the participants of a conference.

But they may surprise us on this, because some types of developments don't require a press release. The best news they could give us today would be to name a target date for submitting a new drug application (NDA) for the second drug in their pipeline ANX-514.

There have also been buy out rumors spread all over the internet about this company over the past two months, but I don't think this has a possibility of happening until after the FDA approves the NDA for their first drug candidate ANX-530. ANX submitted a NDA to the FDA for this drug the last week of December 2009, and the FDA has sixty days to rule if they will accept or decline this NDA or not. We should hear news on this during the last week of February, or during the first week of March.

There are also talks of partnerships with one or more of the big BioTech companies. One of the purposes of a conference like today's is to have private meetings with the CEO's of the presenting companies. News of either a buy out or a partnership would surely be good news for this company, and it should reflect well on their share price.

I will be watching for unusual volume and price action on ANX today and the rest of this week. I will post my thoughts about their presentation later today. ANX is one of the few stocks that I am an "investor" in. I also have another block of shares that I trade in and out with using my day trading account.

Happy Trading,
zigzagman