At Thu, 13 Jan 2000, Gina wrote:
>Yes please do post the reasons--I am deeply disappointed in this news as
>it was really my only hope for a future without pelvic pain and pain
>with sex due to adhesions :(
>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.
>>>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
>>>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.