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Talon Therapeutics, Inc. Message Board

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  • tredleon tredleon Dec 8, 2009 9:34 AM Flag

    good news

    I don't think the CR's in the last 9 will matter all that much. Whether there are none or 3, it won't move the overall percentage in any meaningful way. The question how you think the FDA will approach this drug in a NDA filing - if it is treated as a NCE, there is no way it would get approved. But this is not a NCE, it is a modified version of an already approved drug. The PK/PD of vincristine is well known and documented, and it seems perfectly plausible that if you modify it in a way that allows more drug to reach the tumor cells, it will be more effective. If you believe the company's CEO, the FDA has agreed that the benchmark for proving that premise was 9 CR's out of 56 patients - they have generated 12 with the 56 patients. They will generate additional PK/PD and safety data ( and perhaps another 1 or 2 CR's) out of the additional 9 patients. Will this data be sufficient to convince the FDA that Marquibo is a better (i.e. more effective and no less safe) version of vincristine - who knows? The question for the long-term value of Marquibo is not whether it gets fast track approval in a relapse setting, it is whether it utlimately replaces vincristine in a front-line setting - if you believe it is indeed a better version, it probably will. But in the short run, there are not enough believers that the current data is sufficient to get approval in a relapse setting, so the stock will flounder. If there is long-term value here, the best you can hope for in the short run is a buyout - I don't think any commentary by the CEO will convince the market that FDA approval in 2010 is likely?

 

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