Replies to post #4403 on InVivo Therapeutics Holdings Corp (NVIVQ)

[tootalljones]

Humanitarian Device Exception, per FDA http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/

[voisybay123]

Neither of the first two patients (Jordan/Jesi)were "cherry picked" for entry into this "safety" trial--although both were young that is about the only similarity--Jesi's injuries alone were catastrophic--she had a punctured lung and required several days in an ICU setting to be stabilized--there was a delay in ultimately inserting the scaffold--the fact that she has done as well as she has (the latest video shows she is able to move her legs) is remarkable---there could be an argument that both of these patients were highly motivated to participate in their recovery but that alone doesn't explain their improvement---to silence the skeptics I hope patient #3, #4, #5 are from an older cohort (although again these patients are not "picked" but will arrive following their accident and if they fit the criteria outlined by the FDA guidelines they will be offered a chance to participate in this trial)