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

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