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Re: mjxspxdr post# 803

Tuesday, 05/09/2006 8:32:52 AM

Tuesday, May 09, 2006 8:32:52 AM

Post# of 48498
Mjx, I've followed Cortex since around 2002 and they've always done an audio webcast of the SHM over those years.

FWIW, I'm expected a fairly detailed explanation from Stoll of the nature of the "problem" (ie - was it 1) toxicity/side effect related, or 2) was there a lack of sufficiently high dosing multiples in animals, or perhaps 3) the FDA now wants some animal data on some new clinical parameter, etc). Stoll should then discuss the remedy proposed by the FDA if one has been established (however they may still be in the discussion stage on that with the FDA so details may be lacking), and an approx timeline to complete what is required. At the very least, we should come away knowing the nature of the "problem" that prompted the clinical hold.
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