BioDelivery Sciences International Inc logo

BDSI - BioDelivery Sciences International Inc News Story

$3.38 0.2  6.5%

Last Trade - 07/05/21

Sector
Healthcare
Size
Small Cap
Market Cap £244.0m
Enterprise Value £220.3m
Revenue £112.0m
Position in Universe 4014th / 6858

BRIEF-Biodelivery Sciences announces short-term supply constraints for Bunavail

Wed 14th October, 2015 12:15pm
Oct 14 (Reuters) - BioDelivery Sciences International Inc  BDSI.O : 
 * Announces short-term supply constraints for bunavail 
 * Delay due to recent introduction of new source of standard polymer by the 
   supplier to bdsi's contract manufacturer of bunavail 
 * Says co is interacting with FDA on a daily basis 
 * FDA has told co decision regarding the requested specification change can be 
   expected within days and no later than next week 
 * Says positive decision will allow release of these batches of bunavail to 
   wholesalers 
 * Regardless of decision by FDA, bdsi anticipates having product currently 
   being manufactured in field in November 
 * Issue has no impact on any other bdsi product, including belbuca, which has a 
   pdufa date of October 23 
 * Says assuming a positive FDA decision, any near-term supply outages should be 
   limited 
 * Batches awaiting the FDA decision are more than adequate to meet current and 
   anticipated market demand for bunavail 
 * Source text for Eikon  ID:nPn7myjNv  
 * Further company coverage  BDSI.O   
 
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