At Wed, 12 Jan 2000, Sue Ann Murray wrote:
>
>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.
>>Regards
>>Dr. David Wiseman
>>
>>FDA panel rejects LifeCore's surgical adhesion gel
>>
>>ROCKVILLE, Md. Jan 12 (Reuters) - A federal advisory panel Wednesday
>>rejected
>>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
>>later.
>>
>>The FDA usually follows its panels' advice.
>>