Life Medical Sciences (CHAI) for Hair Regrowth? Message Board

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Biotech / Medical : Life Medical Sciences (CHAI) for Hair Regrowth?

CHAI 2.020

-6.0%

10:32 AM EST

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To: GregSL who wrote (1118)	2/7/2000 12:18:00 AM
From: Art Odell	Read Replies (3) of 1152

Clinical Investigation Plan 1. Introduction -- statement of use -- study plans 2. Intended Use -- specifically what is purpose 3. Feasibility (Pre-Pivotal) -- human testing with small group -- safety is main concern 4. Pivotal -- Effectiveness, effectiveness, effectiveness (With pivotal is the new need for endpoints which requires all data gathering to now include this -- sometimes surrogate source can be used because of limited premarket satistically meaningful data available (LCBM'S scramble to cover themselves -- remember?). This is a problem now with LCBM and I believe Genzyme also had trouble. Document strongly advises working closely with FDA every step of the way to avoid such confusion -- Life Medical Sciences and Dr. Oz are working very closely with FDA even at pre-pivotal phase. You seem to be in error when you locate effectiness trials before pivotal --- pivotal Is mainly effectiveness trial. I was unable to see the old Phase l, ll, lll terminology used in document. After pivotal, as I already mentioned, is further clarification of what is needed ie. endpoints. Endpoints are not another trial but a follow up with the possible addition of surrogate data.. thank you for forcing me to read this more closely -- perhaps you need to as well? Art

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