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Alias Born 03/29/2012

Re: None

Friday, 10/24/2014 9:34:30 AM

Friday, October 24, 2014 9:34:30 AM

Post# of 6306
Probability for success is quite high actually
* Company had always intended to produce a scaffold + cells solution
* Scaffold-only was conceived because this showed unexpected efficacy by itself in preclinical work
* Scaffold alone was subsequently endorsed as an interim path to the ultimate goal and a way to get to market sooner. FDA is onboard with that via its dual approvals in 2013
* Safety is all that needs to be demonstrated in this clinical trial
* Safety has already been abundantly demonstrated pre-clinically
* Safety has been confirmed initially in this human trial
* Any degree of efficacy is a bonus in this clinical trial
* Safety alone is the green light for the next phase which is scaffold + cells & tissue
* Safety plus any degree of efficacy in scaffold alone paves the way to interim revenues via marketing the NSS as intervention in acute cases prior to the completed development of the scaffold + tissues for both acute and chronic SCI
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