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  • jacosa jacosa Oct 14, 2011 11:35 AM Flag

    FDA Approval of Pivital Study

    The study design has clearly been modified since the CC. The description has a certain "horse designed by a committee" flavor. The adaptive design anticipates a likelihood of results much less dramatic than those in the Italian studies. I have no clear idea why that should be anticipated: with many centers, operator training is likely to be inferior in the US, but the device is supposed to be easy to use. Is the rate of CIN already lower in the US? I didn't think it was...anyone know?

    I guess that FDA is super-cautious about any test where the operators can't be blinded (both urine output and IV fluid use are important to know real-time to protect the patient). You can swear up and down that the people doing data analysis will be blinded, but I wouldn't believe it with so much at stake; FDA does well to be cautious.

    If the study goes to 600+ patients, I have serious doubts that PLC has sufficient money in place to commercialize RenalGuard afterward.

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    • This is very good news, jacosa. I also think you are misreading the modified design for the clinical. This is the ONLY horse they got... thinking they just lowered the bar a bit to ensure clearing it.

      BTW, they got another $2M of financing available for post approval marketing.
      Also, what in our US culture even suggests that we'd be any healthier than Italians? They are ALL on the Mediterranean diet ;-)

      • 1 Reply to doc.reality
      • It makes me feel good, but it isn't good isn't news at all. News is the start of actual patient treatment. News is an announcement that the study completion population has been determined. It MIGHT have been news if FDA had approved an obvious gimme study design, but that would be pushing it. This announcement suggests a high level of FDA skepticism (Which is warranted by the history of previous CIN preventive measures--you can find the history of N-acetylcysteine in that use without a lot of difficulty).

        I'm guestimating a study cost around $5K a patient, and an introduction cost of around $3MM. Could make it awful tight. We've seen that the device doesn't sell itself in Europe. That $5K a patient may seem high, but it's practically free compared to the variable costs of registration trials for drugs.