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Biotech / Medical : AVIGEN(avgn)
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To: scaram(o)uche who wrote (194)9/7/2001 1:41:23 PM
From: JMarcus   of 228
 
I've done some research and the picture doesn't look as bad for Avigen as I'd thought after first reading the Tom Abate article.

Clinical trials get temporarily halted and restarted rather frequently. It isn’t appropriate to announce every temporary halt, the exception being when the halt is due to significant adverse events among trial participants. The impact of such announcements on trial participants needs to be considered. It would be unfair to alarm them unnecessarily.

The FDA’s decision to allow Avigen to proceed with the liver induction trial is really all the evidence one needs to know that the mouse study should be discounted as an aberration that had everything to do with the particular gene being transferred and nothing to do with the vector used to transfer it. The FDA informed Avigen of that determination sometime in the Spring, well in advance of the stock sales by the CEO. Obviously there was a time lag between that determination and the August approval for starting the liver induction trial.

Marc
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