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Vaccines, Blood & Biologics

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Fibrocell Label Email, March 24, 2011 - Laviv

From:        Tull, Lori
  Sent:          Thursday, March 24, 2011 12:00 PM
  To:             'Jeanne Novak'
  Cc:             'Dana Weinberger'
  Subject:     FW: Fibrocell Label

Hi  Jeanne,

The  clinical team would like to have a telecon with you if you are available on  Tuesday, 3/29 from 9-10 am regarding efficacy and safety labeling issues.  Please see our questions below.  If that time is agreeable to you, would you  please let me know and provide a call in number?  If not, will you please propose some times  when you are available?

Question  to Sponsor (regarding Time to Onset of Response)

In  your draft labeling Section 14.1, you state that, when two-point improvements  were used as the criteria for a response to treatment, the median time to onset  of response in LAVIV-treated subjects was 130 days for the patient’s assessment  and 123 days for the evaluating physician’s assessment. Please address the  following:

  1. The information displayed appears to be not the  secondary endpoints, time-to-sustained success, specified in the  statistical analysis plan (dated June 17, 2008) for possible labeling claims.  Please clarify.  
  2. For each of pivotal studies 005 and 006, please  provide the median and range of time-to-sustained (i.e., sustained until  the six-month timepoint) success assessed by subjects and by evaluating physicians  for each treatment group.  Analyses  should be based on visit data as shown in your BLA submission.