Replies to post #8565 on Mast Therapeutics, Inc. (MSTX)

[leoncio1]

The first step is de FDA.. this comming days,.. for ANX first product to the marked.. I expect an positive reaction on the pp when the first step is positive.. !!

ADVENTRX Submits Exelbine(TM) New Drug Application
SAN DIEGO, Nov. 3, 2010 /PRNewswire via COMTEX/ --

ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate ANX-530 (vinorelbine injectable emulsion), or Exelbine.


"Our Exelbine submission includes twelve months of site-specific stability data from our intended commercial manufacturer, which fulfills a request communicated to us by the FDA earlier this year. We believe this submission will be accepted for review in early 2011 and we look forward to working with the Agency toward our first product approval," said Brian M. Culley, Chief Executive Officer of ADVENTRX.

ADVENTRX retains exclusive worldwide rights to Exelbine, other than in China, Hong Kong, Macau and Taiwan. In March 2010, the FDA conditionally accepted "Exelbine" as the proposed proprietary name for ANX-530. In October 2010, patent claims related to Exelbine were allowed by the United States Patent and Trademark Office. These patent claims, when issued, will extend into 2024.

ADVENTRX is seeking approval of Exelbine for the same indications as Navelbine(R), 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 Company's 505(b)(2) NDA submission 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.

the Second step.. second product:

ADVENTRX Requests Meeting with FDA to Discuss ANX-514 Study
SAN DIEGO, Dec. 15, 2010 /PRNewswire via COMTEX/ --

ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced it has submitted a request to the U.S. Food and Drug Administration (FDA) to schedule a meeting for the purpose of discussing its product candidate ANX-514 (docetaxel emulsion for injection). The FDA is expected to set the meeting date within 60 days of receiving the request from ADVENTRX.


"We have performed an extensive analysis of the data from our bioequivalence study of ANX-514, as well as on results from other trials using Taxotere(R), and plan to discuss our findings at the meeting," said Brian M. Culley, Chief Executive Officer of ADVENTRX.

"Based in part on the substantial variability observed with Taxotere as reported in the literature, we believe the transitory elevations in total docetaxel concentrations for ANX-514 do not affect adversely its safety or efficacy relative to Taxotere. However, the FDA is the final arbiter of safety and efficacy and, following our meeting, we will provide an update on the next steps and requirements for advancing ANX514 toward an NDA submission," Mr. Culley continued.


Grtz.. leon

[UpstateChris]

Thanks for the update. I was not familiar with 514 being pushed that far out. I am a bit confused on the stability data for 514 though. On the RTF conference call a year ago he clearly stated that they actually had more data on 514 than 530 as it moved to the new manufacturing facility earlier than did 530. Even if that was not the case and he just then had started collecting data, they would have 12 months next week.

Don't get me wrong, it is definitely a good idea to see how 530 fairs the process and then adjust the bigger money maker, 514, accordingly in order to get the highest probability of success. I am just not entirely sure where your timeline comes from. They have a meeting request with the FDA to discuss the 514 NDA (prior to submission). This meeting should occur (to my understanding) sometime before Feb 15, 2011 (based on the 60 day windows from the Dec 15th request). If at that time it is determined that the FDA is comfortable with the data, it takes ANX about 4-6 months to put together an NDA. Given the 60 day windows to accept/refuse that puts the 514 NDA decision about 3 quarters out, with approval/rejection of the drug itself early to mid 2012. Granted, the difference in my estimate and yours is not relevant to any day or swing traders, only long term investors.

If your statement below about not filing an NDA for 2 years is accurate, you would be looking more at a 2014 accept/reject of the drug itself (60+3 days to accept NDA, 10 Months+3 Days after that for approval) plus anything that they have to go back and re-do or any additional panels.