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

To: Art Odell who wrote (1119)	2/9/2000 11:05:00 PM
From: GregSL	Respond to of 1152

Art- From the FDA document: "The purpose of feasibility (pre-pivotal) studies is to obtain preliminary clinical assessments of the safety and effectiveness of the device. These small, usually non-randomized, one or two site studies are intended to evaluate the procedures to be used in the pivotal study, refine the design of the device, refine instructions for use, and provide initial experience to potential investigators. The data derived from feasibility studies are used to design the pivotal trial, estimating the treatment effect and establishing the appropriate sample size for the pivotal safety and effectiveness study. Feasibility studies are recommended when there is no other clinical experience with the adhesion barrier, in order to refine clinical study parameters before the pivotal study." Basically they need to test for effectiveness during the pre-pivotal trials in order to design the pivotal trial. The pre-pivotal trial is usually broken up into two - one for safety (Phase I) and one for effectiveness (Phase II). The pivotal (Phase III) is primarily for effectiveness, but some preliminary effectiveness information is needed. It helps define endpoints, determine trial size and other parameters. Regardless, one more or two more, now you know additional trial(s) will be necessary. Greg- Thank you for your words in support of management. I apologize for my previous comment. Regards, Greg

To: Art Odell who wrote (1119)	2/10/2000 7:52:00 AM
From: GregSL	Respond to of 1152

Art- From your 1119: <<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.>> LCBM was working closely with the FDA. In fact, the FDA approved closing their Phase III trial because efficacy had been proven. For the advisory panel to turn around and reject it was a shock. Demonstrates the vagrities of dealing with the FDA. This board was celebrating the rejection of Intergel. It actually would help CHAI if it is approved. Repel CV and Intergel have different indications. A film would be cumbersome to use in gyn surgery, but would remain in place over the anterior heart better then a liquid or gel. Greg