Clinical data is too weak on efficacy with existing drugs already on the market.
Pete, wake up, the 4-5 vote on efficacy was as much a concern with the unfair end points as it was on if the device works? If you listen to the panel, the majority agreed the device works.
fda approves devices based upon the risk vs benefit ratio. The adcom voted 6 to 2 that the risk benefit ratio is positive. fda will approve based on 6 to 2 positive adcom vote.
efficacy will be the death knell. What good is a device that is safe, but doesn't do anything positive.
They probably will. This replaces procedures that are far more extreme.
It's a Ka-boom as soon as wall street enter in...tomorrow I buy BIG
Sentiment: Strong Buy
you are ignored......
LOOSER!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! written all over your face.......
Looser than what?
I see your spelling is as good as your stock skills. Go buy APPL and shut up.
FDA will do whatever adcom says
Yep, the device is NOT effective.
Told you dopes. FDA won't touch this with a 10 foot pole on a negative ADCOM efficacy vote.
peter eat a weiner
It is a device you dope, not a drug....And the drugs on the market now basically suck. Look how well ARNA and VVUS are doing.