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Spectrum Pharmaceuticals, Inc. Message Board

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      Do they have 1 year data at all ???

    • The SPA was a function of efficacy, surgical failure rate of TURBT and incidence of spontaneous new cancers. Problem with trial design was possible for Apaziquone to have 100% efficacy and still fail SPA. What matters is the details.

      • 1 Reply to yuzzvln
      • hello yuzz,

        I'm not sure of the value of filing an NDA if result of the submission is going to be outright rejection or Complete response letter with request to perform another trial? By the time we get a mtg (2-3 months, another 2-3 months to file NDA with data, then wait for FDA to review data, that's probably like 1 year from now before getting the rejection letter or CRL. After the mtg, if FDA will not allow pooled data or atleast the possibility for conditional approval with an NDA, why bother filing. Aren't we better off doing another trial with shorter end point than 2 yrs?
        The details should be given at the mtg request Raj is trying to have with the FDA. If data not sufficient, not worth to do another study with 2 yr end point, that is 5 yrs away before we even get results.
        Put Eoquin on the shelf and never let the detail results out to the public if there is no benefit to SPPI. Save any clinical trial research $$ for other purpose. I would rather see them push marketing dollars to Fusilev, Folotyn, and get those medical oncologist clinics certified to administer Zevalin.

        "However, analysis of the pooled data from both studies showed a statistically significant treatment effect in favor of apaziquone in the primary endpoint of the rate of tumor recurrence at 2 years (p-value = 0.0174) and in a key secondary endpoint, time to recurrence (p-value = 0.0076). The company is considering to request a meeting with the FDA to discuss future steps."
        Why do you think Eoquin is not as effective as Mitomycin? You suspect lower failure rate of TURB and higher incidence of new bladder cancer than normal. If time to recurrence is SS in the pooled data, doesn't that mean its effective (kill) cancer cells that may transplant somewhere else in the bladder immediately after TRUB? Must be frustrating when we all have no detail data and a bunch of assumptions that could be totally incorrect.

    • The mission of the FDA is to bring safe and efficacious drugs to market to reduce the morbidity and mortality of serious diseases such as bladder cancer. Pooled data and SPA is not the issue. This was a very tricky and complex trial design with three main variables. The only direct measurement of efficacy is difference between treated group and control group at 3 months. I agree with csat that meeting with FDA will result in SPPI filing a NDA.

    • 100% on ...

    • That would depend on the test data. If the results show a clear bias towards apaziquone at year 1, nothing's impossible.

      Anyway, I believe that if the meeting with the FDA results in SPPI filing a NDA, would give the stock a boost as if the trial had been succesful.

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