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Protalix BioTherapeutics, Inc. (PLX) Message Board

kavbrian 4 posts  |  Last Activity: Mar 25, 2015 10:33 AM Member since: Aug 17, 2008
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    Lung cancer trial

    by oncodoc02138 Mar 25, 2015 6:50 AM
    kavbrian kavbrian Mar 25, 2015 10:33 AM Flag

    Thanks for the post about the lung cancer trial. I too have been wondering when the data will be presented. As for the lack of any love I think 3 factors are behind this: 1) A pivotal trial is beyond the financial means of EXEL. 2) They are not in a good position to negotiate a partnership due to lack of appreciable earnings, cash burn, and debt 3) The lung trial was controlled but small (50 patients or so per group).

    If METEOR PFS is positive with manageable side effects and Cobi is approved early in melanoma I think things will change considerably. If they are waiting until ASCO to present the lung data this might bode well. But who knows...

  • kavbrian kavbrian Mar 1, 2015 12:49 PM Flag

    Those are some interesting comments/speculations concerning a sNDA filing. I have a few questions for you. Would a sNDA filing need to be reported publicly? Can they keep that a secret? Have they had enough time to pull all the data together for a sNDA filing? COMET-1 was about 1000 patients. Normally that takes about 6 or more months (although I guess the mfg stuff was previously submitted with the MTC filing). I am interested to hear your feedback...

  • kavbrian kavbrian Feb 11, 2015 9:27 AM Flag

    I hear you enabler! So many times in the past the EXEL sp has gone up just prior to a quarterly CC (or investor dog and pony show CC) just to come back down the same or the next day. This time the volume is encouraging though.

    Sooner or later they will release the phase II lung cancer data. That trial was small (150 patients) but heck at least it was controlled with an active drug. Time will tell...

  • Reply to


    by saltydog711 Jan 28, 2015 10:56 AM
    kavbrian kavbrian Jan 28, 2015 1:59 PM Flag


    what presentation are you referring to? I have been waiting (hoping, well actually praying) for Cobi/PDL1 news. thanks! I hope this does not post multiple times. this is my third try...

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