Biotech Values

[ghmm]

Yeah cyberonics did get the device approved on appeal (the panel had recommended approval before the non-approvable I believe). I only remember it because it ranks high in my list of entertaining conference calls:

Some of the 8k
http://yahoo.brand.edgar-online.com/EFX_dll/EDGARpro.dll?FetchFilingHTML1?SessionID=Z1NsjDYNNDh4Mrg&...

We are shocked and bewildered by FDA’s decision to ignore its expert Advisory Panel’s recommendation,” commented Robert P. (“Skip”) Cummins, Cyberonics’ Chairman of the Board and Chief Executive Officer. “FDA’s Center for Neurological and Restorative Devices had no prior depression experience before the VNS submission and as a result, FDA deputized four of the seven voting members of its expert Advisory Panel. All four of these deputized members were psychiatrists, including three who also serve on the antidepressant drug Advisory Panel. All of the reasons cited in yesterday’s not-approvable letter were addressed at the Panel meeting on June 15 prior to the Panel’s vote recommending approval. FDA has now chosen inexplicably to ignore not only the recommendation of its panel of experts, but also the strong recommendations of numerous psychiatric thought leaders and the compelling testimony and needs of people with treatment-resistant depression who today have no long-term treatment for their lifelong and life-threatening illness.”