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La Jolla Pharmaceutical Co. Message Board

  • neverabogey neverabogey Oct 28, 2004 3:50 PM Flag

    today is 10 business days from

    the decision to push us down, they said ljpc would have to meet with the fda within 10 to discuss the future of this drug, we should hear something soon, good or bad

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    • Organic,

      Thanks a lot for the info. This makes me a little more confortable in wating.

      Thanks again!

    • must_learn_what_ed_knows must_learn_what_ed_knows Oct 29, 2004 2:26 AM Flag

      Mr. Mo_Jo -

      You just mentioned the lynch-pin in the Phase IV trial, the dosage.

      Alex - you're gonna have to wait - it should be worth it.

    • This is not correct, FDA policy says that LJPC has 10 days to request a meeting. The FDA will then set a meeting within 45 days or less.

      Hang in there longs, this drug works and it will simply take a bigger and better designed trial to show its significance. Lupus is too complex a disease with too many variables and random remissions and relapses so it takes either many patients or many years to do it properly. The mitigating factor of course was that both test and control groups were immuno suppressed with secondary medicines dampening the effect of Riquent. All these issues are dealth with in the next trial. In either case even both of the former smaller phase 3 trials showed positive improvement with statistical significance in the first year. Since this is the trial duration of the final trial it is simple to deduce that Riquent will be successful. So all longs just hang in there, don't take losses, all good things are worth waiting for, and those who believe in this technology will be rewarded in the end...

      Live LONG and Prosper

 
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