Support: 888-992-3836
Copyright © 2023 InvestorsHub Inc.
Replies to post #188244 on Biotech Values
DewDiligence
03/06/15 9:11 AM
#188257 RE: RealGenius #188244
While Sunshine Heart is pleased with the study's progress in terms of the recent enrollment pace and site interest, it will be taking a temporary pause from enrollment. This is in accordance with the study protocol where in the event more than three of the first twenty subjects pass away for any reason, including non-device related deaths, the Company will work with the FDA to discuss a plan to resume enrollment. To date, of the four reported patient deaths, two have been adjudicated by an independent Clinical Events Committee (CEC) as being non-device related. The Company has received study documentation from the sites that reported the most recent two deaths that these were also non-device related. Patients already in the trial will continue follow-up according to the protocol.
semi_infinite
03/13/15 3:20 PM
#188577 RE: RealGenius #188244