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(System Info - 126202 TULL LORI 04/16/2010 13:09:55 TULL)

From:          Finn, Thomas
Sent:          Wednesday, January 06, 2010 9:45 AM
To:             Smith, Liz
Cc:             Tull, Lori
Subject:       A few more CMC questions
 

Hi Liz,

I know you’re busy over there but I have a few, hopefully quick questions:
  I noted in some of your lot line listing that the b(4) in the APH ranged from 
  as little
  as b(4). Some times this seems to be attributable to the patient because 
  similar numbers are obtained
  from the same patient for 2 or 3 of the APH, whereas in other cases it varies 
  a lot from the same patient.
  When the percentage is very low do you still follow through with the SOP and 
  perform the b(4)
  I assume the answer is yes, but just wanted to check. With regards
  to the upper end of the spectrum, when the percent b(4) is high can that be 
  attributed to a
  leukapheresis problem or differences in the efficiency of apheresis equipment? 
  Have you noted any
  differences in the APH quality from different apheresis sites over the years?
  In amendment 33, table 8 “Summary of leukapheresis and Product Infusions, 
  Intent-to-Treat
  Population” you have indicated that for sipuleucel-T treated patients about 
  1/3 of subjects required a 3rd
  leukapheresis. Was that typically due to complications with the apheresis that 
  required another visit, or were
  there situations where insufficient APH volume was collected or an in-process 
  or final product release
  criterion was not met?
  In amendment 33 you have listing 16.2.6.13 (begins on page 4890 of 5667) that 
  provides a line
  listing on cell product parameters. It appears that roughly 10% of the time a 
  product lot was not infused. I
  assume most of these were due to medical reasons. Were any of these due to a 
  product not meeting inprocess
  or final product release testing? Were any of them not infused because the 
  shelf life (dating period)
  had expired?
  I don not need answers to these questions immediately (I have plenty to keep 
  me busy), but would
  appreciate some feedback from your end.

  Thanks,
  Tom
 

   