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clock Created with Sketch. 02/03/15
16:23
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Originally posted by Brickwalls
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TIS had this to say in their ASX spotlight preso."One 12 month pivotal trial for FDA approval for sale for treatment of venous ulcers Application submission to FDA approved subject to submission of a plan for 1 additional QC test -250 patients prospective, randomised, control trial with double blinding: exceptional scientific standard for wound trial -Detailed statistical analyses to calculate number of patients, delta over standard of care and statistical significance -Clinical Investigators and CRO in place -Clinical trial sites in place VitroGro® ECM protein classified as a combination device/biologic by FDA: practical commercial advantages: -No limit on number of clinical trial sites -Reimbursement involves a single negotiation with CMS; avoids device negotiations with individual US private insurance payers"
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thanks to both of you for your information. Seems reasonably good (though slow go )
