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Biotech / Medical : Life Medical Sciences (CHAI) for Hair Regrowth? -- Ignore unavailable to you. Want to Upgrade?

To: GregSL who wrote (1118)	2/7/2000 12:18:00 AM
From: Art Odell	Read Replies (3) \| Respond to 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

To: GregSL who wrote (1118)	2/7/2000 10:27:00 AM
From: Gregory Messenger	Respond to of 1152

Greg Please don't question management integrity in Chai. Mgmt has not given any of us the impression that they are right around the corner from approval. IF-and I repeat, IF anything is going to happen with Chai in the next several months it will be alot more along the lines of a new strategic (ie cash flow) partner or a buyer. They've had very large buyers in the past and refused, they wanted to go it alone. So, if they had buyers before Phase 1 clinical trials, doesn't it make more sense that attention would be higher now-If the product works? Seems to make sense to me. The last private placement raised $750,000, almost all of the PP was bought by "insiders" at nearly market terms-don't you think they know what they are betting on?