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Biotech / Medical : ADVENTRX Pharmaceuticals Inc (Anx) -- Ignore unavailable to you. Want to Upgrade?

To: ggamer who wrote (214)	8/4/2007 3:00:47 PM
From: Keith Feral	Read Replies (1) \| Respond to of 418

CC summary - Vinorelbine is going to finish recruiting in the next 2 to 6 weeks. The company is pushing very hard to make that happen in the next 2 weeks. It is on their "rush list" and the company is being very conservative in public disclosure, but "most accelerating within the company." The company will have a pre NDA meeting with the FDA in the 4th quarter and a NDA shortly thereafter. Thiovir had a delay with it's US pre clinical meeting. They should have a response letter from the FDA next week to address the additional information. International trials are still planned for this year. The company still plans to file an IND for the drug by the end of the year in the US. Docetaxel had a pre IND meeting with the FDA earlier this year. The company is hoping to identify a 505 b 2 trial for the drug later this year. The company will start trials by the end of the year once they determine the most expeditious pathway. Cofactor is the big daddy, even tough Vinorelbine is closer to market for generating revenues. The phase 3 trial has enrolled 50 centers, with 15 centers pending review. They plan to expand the trials into Europe with positive phase 2 b data, so the company can file in Europe with a single phase 3 trial. The expansion of the trial from the US to Europe may enable the EMEA to consider the single phase 3 trial. The acceleration of enrollment centers in the US and Europe would enable the company to complete enrollment by the end of 2008. The company is in weekly review with the CRO regarding the phase 2 b results. The final database will be locked out in mid September, and the company hopes to release the top line results by Sept 30 or very early October. The company is giving themselves a bit of leeway. The company will also release the full results of the data for the ASCO meeting in January. The company does not know how far into the data they will get in October. Obviously, they won't be releasing the survival data in October, that's an easy one to hold back. The primary results will be for the safety results. The market opportunity for leucovorin in $500 million, but the vast amount of the sales are generic. If the sales reflected the same reimbursement for branded isovorin, the sales would exceed well over $1 billion. At the same time, cofactor eliminates the need for chemotherpay induced anemia drugs that are currently under attack. The burn rate is $5 million per quarter and will increase to $6 to $8 million per quarter as development programs increase. "This is good spending". Also, this development activity increases capital raising opportunities wrt partnerships or other opportunities. As the company crosses new milestones, the value of these deals are increasing.