HIFUS addendum

[Guest guest]

> Nine papers

> published to date on HIFUS and fibroids: 4 animal studies, 4 early

> investigative studies on the technology, and 1 human study--the Phase

> II study done at Brigham's.

Forgot to mention one other thing: the FDA ob/gyn device panel will

not release information on the final details of Insightec's Phase III

clinical trial application until June 2, 2004. One day before the

panel convenes on June 3. This is SOP for the FDA -- but effectively

prevents anyone from being able to say much of anything about a given

device application submitted for approval. Afterall, what could the

public say about the single human (Phase II) data published to date on

this procedure without additional input from the larger Phase III

study? Particularly since comments to the FDA were due by May 26 --

while information submitted by Insightec won't be made public until

June 2. Nice catch-22 going on there at the FDA. It's been a problem

in the past...and is a problem today. Why do you think this catch-22

exists? Why isn't the information submitted to them by a device

manufacturer available to the public prior to the " due " date for comments?

And, why and how is it that a fibroid drug treatment like mifepristone

can languish by the wayside for a decade or so...while HIFUS sails

through without commentary? Money. If GE had a vested interest in

mifepristone the way they do with HIFUS...mifepristone may well have

been approved eons ago. Mifepristone would treat ALL fibroids...not

just 1 or 2 'select' fibroids. But, it won't bring in the revenue

that HIFUS will...

Carla