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Spectrum Pharmaceuticals, Inc. Message Board

  • tartiaboy tartiaboy May 14, 2014 2:25 PM Flag

    Apaziquone PIII

    News of the initiation of Apaz PIII should come soon. My rationale. The Apaz PIII must be started and substantially enrolled before the Apaz NDA can be filed and accepted by the FDA. SPPI has repeated that they expect to file this NDA by the end of the year. This cannot occur unless they get the PIII filed in the near future. . This could move the stock.

    We are also very close to ASCO and could get the efficacy data for CE-melphalan very soon.

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    • Spectrum's recent presentation says "File NDA for Apaziquone and Start Phase 3", not vice versa. It sounds like they are going to file first and start study later. Not sure about the logic for that.

    • "We are also very close to ASCO"

      ASCO abstracts are out, i'm not very good at searching them, but thought I would mention it for others.

    • Sounded to me like the trial would have to be sufficiently enrolled such that they would expect it to be fully enrolled, or almost such, by a decision date on the NDA. That to me implies they are already way late on launching, and will likely not see 2014 submission even if the trial opens tonight. The only thing I know of that would offset that analysis would be a trust in Raj. Yeah.

      Long here, but have serious doubts about the Apaz registrational pathway anyway, The submission on the combined data has to strikes:

      . It is statistically dubious to combine 2 trials that were not designed for such.
      . As it now is a single trial, the "bar" at the FDA is higher than if it was still 2 trials.

      And this is not baseball.

      Plenty enough value in the other drugs to get this ship righted regardless of Apaziquone.

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