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Celsion Corp. Message Board

  • odaat_the_cancer_fighter odaat_the_cancer_fighter Nov 10, 2012 10:36 PM Flag

    DMC Meeting

    With all respect to my dear friend Westwell, it's not just daat the company doesn't want to interfere with the DMC members' holidays. Jeff Chirsh still thinks his Ravens are gonna make it to the superbowl this year, so I have a suspicion they want it all done and to the DMC at least before the divisional playoffs, definitely before conference championships. Add to that that Dr. Fleming teaches BIOST524, which, ironically, is Design of Medical Studies, on Tuesdays and Thursdays in January, and he is not known to be one that likes to let grad assistants teach his classes. Add in travel time, and I figure the DMC meeting is likely Friday, January 11th. So guesseth Odaat.

    Plenty of time for me to get my 2013 buys in before data.

    Holidays and hurricanes...getting in the way of the cancer answer. Oh well, perhaps it's not global warming after all, but rather, Celsion, that is the real cause of all this HEAT.

    - Odaat, meteorologically.

    Sentiment: Strong Buy

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    • Hey Odaat

      So you are thinking 380 happened around Oct 8th, Then DMC meeting Jan 11th? So about 12 weeks...
      After that how quickly do you think CLSN makes DMC results public?

    • Odaat, Are you saying that Dr. Tom Fleming is on the DMC? Was he on the DMC when the decision was made not to stop the trial early? Is this public info or is there any way you can confirm? (It is clear from PRs that HEAT used the O'Brien-Fleming stopping boundary, but they do not need him personally for that). TIA

      For those who are not familiar, Dr. Fleming is an outspoken and influential critic of progression-free survival as a primary endpoint in trials. He has a very strong personality and, in the world of DMCs and statistics, is a superstar thought leader. Dr. Fleming would probably push the whole DMC to wait for good overall survival data before stopping the trial and contaminating future data -- even if PFS data were fantastic at the interim. (Dr. Fleming does not believe that PFS is, in general, meaningful to patients.)

      Dr. Fleming's presence on the DMC would limit the argument that "because HEAT was not stopped early, tdox+RFA cannot be blowing away RFA alone in terms of PFS."

      Tdox+RFA could still be blowing away the PFS for RFA alone.

      Sentiment: Strong Buy

      • 3 Replies to nevil_h
      • Nevil
        1 Tom Is chairman of the Celsion DMC
        2 FDA has agreed that PFS as a surrogate is sufficient for conditional approval
        3 No One said anything about stopping the trial at the interim. Enrollment was essentially complete at the time of the interim. Decision was whether to submit or not, not whether to stop trial or not.
        4 It has always been the intent to get OS for unconditional approval. This implies allowing ongoing patients to be followed until death without changing their treatments even if decision was made at interim to submit data.
        5 Since retreatment is SOC there is no guarantee that increased PFS will result in increased OS. Theoretically it could just mean fewer retreatments for TDOX group with same survival.
        6 getting enough OS events will take much longer than getting PFS events because average survival is much longer PFS.

        Just your average fifth grader, Kid Celsion

      • Nevil, thanks for that information on Dr Fleming. I agree with your conclusion. And if there is a significant group of the ThermoDox arm that have been cured, then the O/S numbers are getting better and better as time passes. Both sets of numbers, PFS and OS, could be very strong by now.

      • odaat_the_cancer_fighter odaat_the_cancer_fighter Nov 12, 2012 9:22 AM Flag

        Yes, friend, Dr. Fleming leads our DMC. I happened to be replacing a blower motor in the HVAC system during a 2010 DMC meeting and thought I heard his voice, so I climbed into the return vents and there he was, leading the "level 2" meeting. Celsion was kind enough to forego that level and respect the DMC, but the Yakult guys insisted on being in it. When they went into the DMC only, "level 3" meeting, it was only Fleming, the other members (whose names I will not mention), and good ol' Odaat listening from the ducts. My one large left ear alone entirely covers an 8 x 14 return grille, so I hear it all with no interference.

        And you are right about all you say about him as both THE preeminent med stats guy, and his feelings about PFS, and how much it's clear that Celsion has run an IMPECCABLY WELL DONE study, and placed THE top dawg on it as its monitor and gateway.

        This is going to be huge. I'm thinking of enrolling in his Medical Trial Design course through distance learning.

        - Oskype

        Sentiment: Strong Buy

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