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Enzon Pharmaceuticals Inc. Message Board

  • riffissimo riffissimo Nov 30, 2004 10:15 AM Flag

    Interesting Comparison with Ilex

    The sample sizes (post-FDA hacking) are similar and responses are in a similar category. Yet the Ilex review defers conclusions to the ODAC discussion, and the Inex review feels free to tell the ODAC panel what to do.

    I get the feeling that there's a really frustrated person/statistician at the FDA that you don't want on your review team. Academics love to say the data isn't good enough, but the rest of us in the real world would rather err on the side of getting new medicines to the oncology field. OK. Maybe we want to take longer looks at our erectile function drugs, but lets get some of these cancer options out there.

    I would want Marqibo in my regimen...

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    • You sound very pompous in your evaluation of the FDA. Read the document, how can anyone say that what was submitted proves ANYTHING but bad study design an protocol adherence. You want marquibo in your regimen?, why? what has been proven? Pompous attitudes comes from being cocky, you must be from one of the companies that thinks this submission is worthy of high science. Its CRAP. I'm glad the FDA can see through smoke and mirrors, exposing short sighted industry rookies.

      • 1 Reply to zebar46
      • Study design? The FDA is there in the beginning to talk about study design. That's the time to talk about study design.

        You're looking in the wrong direction for arrogance. I'm an advocate for patient/doctor choice. A better Vincristine?... you bet I would want that. You bet I DID want that option for my relative who died from lymphoma last year. At the 3rd line of treatment, you'll look for anything that doesn't hit too hard at you're already low blood counts.

        Imperfect, yes. I'm amazed that Inex couldn't even use a fairly standard measure of disease (1cm). Yes, Inex allowed a heterogenous population into the study (good for the patients with no options). Yes, they allowed a lot of other imperfections.

        You're caught up in ivory tower, elitist, pipe smoking rhetoric. The debate isn't whether all of the rules were followed, how impressive the study coordinators were, or how much money was spent. The debate is whether Marqibo, based on the audited data, is effective and relatively safe for treating lymphoma. 20%+ ORR as a single agent, and relatively low hematologic events (given the population) tells me to add this to a regimen of relatively safe candidates (rituxan, cyclophosphamide, prednisone...).

        I think the fact that Marqibo is derived from an already existing drug (vs. something as unique as Rituxan was), also plays a role in the ivory tower debate. Stay focused here. We want new drugs with new mechanisms, but we also want to improve old drugs.

    • although the data are similar, i think the difference in the fda review panel repsonse is due to the difference in the statistical validity of filing on randomized phase 3 data as opposed to single arm phase 2 data. that said, the marquibo phase 2 data are outstanding and i think the odac panel will go thumbs up.

 
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