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Vaccines, Blood & Biologics

OCTGT Consultation Questions Email, February 23, 2011 - Laviv

From: Alexander, Janette
Sent: Wednesday, February 23, 2011 10:43 AM
To: Tull, Lori
Subject: RE: OCTGT consultation questions

 
I’m sorry but I will not be able to provide a detailed consult and review at this time due to a conflict with a PMA panel presentation. My brief comments to these questions are as follows:
  1. Inflammatory infiltrate and fibrosis should be correlated with clinical induration or palpable masses
  2. I believe evaluation of 6 month data is essential to predict the clinical course.
  9.   I do not believe the risk of donor site scarring has been adequately documented and that it is also not reflected in the labeling.  Hypertrophic and keloid scars occur with some frequency in the postauricular area.  Risks should be made clear.

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