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Omrix Fibrin Pad Follow Up Email, July 10, 2012 - EVARREST

Tilghman, Tracy

From:                                Lindsey, Kimberly

Sent:                                 Tuesday, July 10, 2012 1:47 PM

To:                                     Tilghman, Tracy; Ananyeva, Natalya

Cc:                                     Barash, Faith; Brown, La'Nissa; Golding, Basil; Mintz, Paul

Subject:                             Omrix Fibrin Pad follow up items (PMR/PMC) for immunogenicity and repeat exposure

 

Dear All,

At the end of the midcycle meeting there were two outstanding clinical items regarding PMR/PMC:

·      Is a PMR needed for immunogenicity?

·      Is a PMR needed for repeat exposure?

 

I discussed the issues with the DH management in attendance for the midcycle meeting (Drs. Basil Golding and Paul

Mintz).

 

They are in agreement that since Omrix has an ongoing US program to obtain a general adjunct to hemostasis indication, the immunogenicity information can be obtained during the ongoing US clinical development program. Omrix will be collecting immunogenicity information in a recently submitted IND (---b(4)------------------------------------------------------------------------------. In addition, they collected immunogenicity information in their non US studies. This information is in the BLA currently under review.

 

As for the repeat exposure, in our advice letter for IND –b(4)- sent to Omrix on June 29, 2012, we asked Omrix to submit a repeat dose toxicity preclinical study.