Title: Cyberonics asks FDA to reduce reqd study size
Bernard - January 26, 2009 04:05 PM (GMT)
| QUOTE |
January 7, 2009
Medical device maker Cyberonics Inc. said Wednesday it has asked the Food and Drug Administration to approve reducing the number of patients involved in a post-marketing study of its VNS Therapy system for depression.
The request to trim patient enrollment to 330 from 460 follows a prior FDA amendment to data originally used to design the post-marketing study. Cyberonics said it would still be able to maintain the same study power with the lower amount of participants. ... |
Birdbomb - January 26, 2009 05:49 PM (GMT)
They want to chop off 120 potential victims. hmmmm.... : g : interesting. It doesn't really specify why, but if they are making the patient pay for their own VNS they may not be able to get enough people for the study. That marketing promise of $25,000 price tag which in all actuality is closer to $75,000 may be a big deterrant for many test subjects.
It's going to be interesting to see how the FDA mishandles...oops I mean handles this.
Bernard - January 26, 2009 07:24 PM (GMT)
oreo - January 27, 2009 11:36 PM (GMT)
I find it interesting that Cyberonics has never contacted me for input on the benefits I have received. I know they were mandated to do a separate study...but why aren't they asking for input from everyone who has been implanted?
Oreo
Bernard - January 27, 2009 11:53 PM (GMT)
| QUOTE (oreo @ Jan 27 2009, 05:36 PM) |
| ...but why aren't they asking for input from everyone who has been implanted? |
Clinical trials are supposed to have a well defined criteria for patient participation (establishing a baseline for the study) and, depending upon the study design, random assignment or blind controls. You likely did not go through whatever screening process they have for the study (to know where you fit against their baseline) and even if you had, it wouldn't be very scientific if Cyberonics could pick and choose which existing patients they wanted to include in study data.
Dispatch - January 28, 2009 12:00 PM (GMT)
<_<
Wonder what next...
B)
Bernard - July 29, 2009 02:04 PM (GMT)
Looks like the FDA granted CYBX's request:
| QUOTE |
HOUSTON, July 24 /PRNewswire-FirstCall/ -- Cyberonics, Inc. (NASDAQ: CYBX) today announced that the U.S. Food and Drug Administration ("FDA") has approved the company's proposal to amend the protocol of its D-21 post-approval dosing study in depression patients treated with VNS Therapy™.
The company submitted a proposal in November 2008 to reduce the number of study subjects from 460 to 330 and completed enrollment of 331 study subjects in February 2009. With this decision from the FDA, the company expects to complete the follow-up on all patients enrolled in the study by March 2010. |
Dispatch - July 30, 2009 12:19 PM (GMT)
<_< There's your mishandles Birdbomb...