SHC sunshine heart, inc.

july - august - september - in one months time will be the next...

  1. 1,224 Posts.
    july - august - september -

    in one months time will be the next quarterly with the company setting a target of double digit enrollments
    question is , how many enrollments can we expect ?

    "We are pleased to report, that with the current volume of patients in the pipeline, we expect Q3 enrollments to reach double digits as over 30 patients have already been identified. Four physician meetings to discuss study participation.
    In fact, it's important to note that every center has identified at least one patient who fits the studies pre-enrollment criteria. 15 total sites were activated and able to enroll by the end of Q2 up from 13 over Q1. An additional two activated sites are awaiting clinical contract amendments which should resolve in Q3.
    With 18 additional sites committed to participate, this bring our total number of participating study sites to 35 and as of today 16 sites are capable of enrolling patients with another two waiting for dendum [ph] signatures which will enable full activation." Dave Rosa

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    JACC + Media blitz created good exposure however its too early for these events to have a bearing on enrollment as they happened in october .

    can we expect double digit ? 10+ ? or more .. cuz anything under this number will be very negative , however a big number and a good quarter will move us away from this level definetely

    kim has been in charge of the trial since 28-4 , her real test has to be this quarter if the steps taken by the company have had an effect.

    interim analysis reply from the fda ?

    more implants in europe ?

    thoughts ?
    Last edited by tootip: 13/10/14
 
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