From: Sue Ann Murray (
Wed Jan 12 21:22:32 2000

I'm wondering if this might mean Lifecore will extend the clincial trials. It definitely made a difference for me. I'll be interested in hearing more about the spedific reasons why it was rejected.

Sue Ann

>Dear All
>I am sending you this message via the message board becuase I don't have
>my computer to send you this personally by email.
>I have just come out of the FDA panel meeting on INTERGEL. It was
>recommended that the product NOT be approved. This means that it will
>not be available any time soon. There are many reasons for the panel's
>decisionn which are too length to discuss here. A press release is
>copied below. Nonetheless I will give a fuller account about this in
>the next week or so.
>This dissapoiting news heightens the urgency for us to hget on with our
>activities of the Intrenational Adheisons Society especially our metings
>in the Philadelphia on Jan 26 and in San Fran on Feb 29(?)
>More news to follow.
>Dr. David Wiseman
>FDA panel rejects LifeCore's surgical adhesion gel
>ROCKVILLE, Md. Jan 12 (Reuters) - A federal advisory panel Wednesday
>LifeCore Biomedical Inc.'s (NasdaqNM:LCBM - news) Intergel, a product
>designed to
>reduce internal scarring after gynecological surgery.
>A Food and Drug Administration advisory committee voted 5 to 2 to
>recommend that the agency turn down LifeCore's
>application to sell the product in the United States. Panelmembers said
>they were not convinced that LifeCore's studies showed
>Intergel provided a meaningful benefit.
>``From a clinical standpoint, I think we're hard pressed to say this
>device makes a difference,'' said panel member Dr. Barbara
>Levy of Yale University School of Medicine.
>Intergel is viewed as a key product for LifeCore's future growth,
>company officials and analysts have said. Intergel was
>designed to reduce the incidence and severity of post-surgical internal
>scars, which can be painful and cause problems years
>The FDA usually follows its panels' advice.

Enter keywords:
Returns per screen: Require all keywords: