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Re: None

Monday, 11/27/2017 5:48:06 PM

Monday, November 27, 2017 5:48:06 PM

Post# of 36440
Ohio State logistically has a strong impeding challenge for enrollment. Currently 10 to 12 patients. Women are asked to stay an extra day following the mammogram if they want to also implement/Supplement the ITBRA as a secondary efficacy metric. Women are choosing to have a Mammogram and same day biopsy if warranted. Women are choosing the all and one day confirmation post Mammogram and do not want to add the extra day per the ITBRA protocol (overnight stay-lost day of work and hotel expense-not sure if reimbursed, doubt it). For some reason EL-Camino must have a more efficient protocol. I am hoping for a LLBO direct update, not just Cyrcadia updates. Keep checking the LLBO site, hopefully in the next few weeks. Remember, per the trial protocol, 12 to 24 hours wear duration. The new version I believe, has far less duration of wear (2 to 12 hrs, if I remember correctly). I am not sure how many patients are required at a different site for enrollment completion, i.e. multi-centered trial. I do know that the 2018 launch is still projected. I guess we will see.