Brief: Cesca gets FDA feedback device to treat critical limb ischemia

Almunda Professionals NV

02/01/2015 10:59

Jan 2 (Reuters) - Cesca Therapeutics Inc  KOOL.O : 
 * Receives feedback from the FDA on its pivotal investigational device 
   exemption ("ide") application for treating critical limb ischemia ("cli") 
 * Says in its letter, the FDA noted several deficiencies in the company's 
   submission 
 * Says "now in the process of addressing the various points raised in their 
   letter" 
 * Says FDA requests, among other things, additional information on 
   characterization of the output of the surgwerks 
 * Says the FDA noted no deficiencies relating to the company's overall trial 
   design 
 * Says anticipate submitting amended ide application sometime in February 2015 
 * Says "look forward to addressing the agency's remaining concerns and 
   resubmitting our application" 
 
 * Source text for Eikon  ID:nGNXVCKFQa  
 
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