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Biotech / Medical : Cambridge Heart (CAMH)-What is this??? -- Ignore unavailable to you. Want to Upgrade?


To: James Silverman who wrote (12)9/11/1997 2:35:00 AM
From: John Zwiener  Respond to of 33
 
James, there is increasing activity in this stock, hear anything. I'm still a believer in this technology. Time frame has been moved back. We should be getting some new study results one of these days.

As you probably know, the particular study that was going to get rapid approval to claim they could pridict sudden death, was designed with the FDA's help. But the centers where they were conducting the study were doingcardiac caths immediately so that their instrument, which is a stress test, could not be run within the required timeframe. So they could not get enough patients with acute MI's. This is where the big population is and where the test is supposed to be best.



To: James Silverman who wrote (12)4/3/1998 12:28:00 AM
From: John Zwiener  Read Replies (1) | Respond to of 33
 
Haven't posted here for a while since no really new news. But now we are approaching report time. If you remember, the first attempt to run a trial for labelling approval to say something like "the finding of
t-alternans waves is correlated with an 85% risk of sudden death within one year (the patient is a candidate for a pacemaker)". That first trial was not able to accrue enough patients due to the trial design, and the location of the studies (the centers would immediately cath the patients preventing timely use of the instrument).

Now this time around, it looks like they have completed the study, or are getting close to it. If this study is anything like the smaller, scientific studies have continued to be, the results should be good. I think they are scheduled to present data in a month or two. Worth looking at again if you haven't lately.