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Cytokinetics, Incorporated Message Board

  • dctrig dctrig Mar 9, 2013 8:21 PM Flag

    ALS Association Pushing FDA Hard

    Dec 12, 2012: Lucie Bruijn, chief scientist at ALS Association, participates in CYTK's panel conference in New York. (Webcast may still be available).

    Feb 25, 2013: Bruijn states "We currently are in one of the most exciting times in the history of ALS drug development.” She commented on the promising number of treatments in clinical trials and the fact that the pharmaceutical and biotech industries are joining the search for ALS treatments at a greater pace than ever before."
    (Go to ALS Association for more details of the meeting at which Cytokinetics was present).

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    • I was personally sad to see the Biogen Idec trial fail as there is room for a number of ALS drugs, just as there is with Aids and cancer. The FDA, to its credit, convened the first ever ALS specific panel and INVITED all the participants. If the placebo response rate in the Tirasemtiv trial is not unusually high and CYTK's drug shows good results in slowing or even stalling progression, all patients could be switched to Tirasemtiv to continue beyond the trial and the FDA could invite CYTK to file an NDA (six month review) and followup phase 3 trials.

      In the above scenario the media will jump on this with exaggerated claims of a cure and CYTK's stock price will go hyperbolic.

 
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