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Fax - RE: BLA125391 - PI, May 21, 2012 - HPC Cord Blood

From: Freed, Brian [Brian.Freed@ucdenver.edu]
Sent: Monday, May 21, 2012 2:53 PM
To: Sista, Ramani V; Miller, Sharon
Cc: Aubrey, Michael; Fan, Yong
Subject: RE: BLA125391 - PI

Attachments: FDA_PATIENT_TRANSPLANT_DATA_05212012.xls; FDA_PATIENT_TRANSPLANT_DATA_05212012N64.xls; STN 125391 ClinImmune Package insert Label V 5-18-12.doc; STN 125391 ClinImmune Package insert Label V 5-18-12_Clean.doc

Dear Ramani,

 

We looked at current outcome data (now up to 64 reports), and then looked at the first 47 by date of transplant.  We came up with 77% male and 23% female with 34% infusion reactions in the first 47.  However, the median age was 26 years (range 0.4-72).  The difference may be due to the fact that we get new reports with data that may have been from a transplant performed much earlier, but only now reported.  When we expanded the analysis to all 64 reports, the median age was 18.   I’ve included an Excel spreadsheet of the first 47 and the current data with 64.  In both instances, the infusion reactions were 34%. 

 

It looks to me the data in the PI are accurate for the time they were submitted. 

 

I’ve accepted the tracked changes and I’m sending back both versions. 

 

Brian M. Freed, Ph.D., DABHI

Professor of Medicine and Immunology

Executive Director, ClinImmune Labs

12635 E. Montview Blvd, Suite 300

Aurora, CO  80045

303-724-0535

 


From: Sista, Ramani V [mailto:Ramani.Sista@fda.hhs.gov]
Sent: Sunday, May 20, 2012 7:38 PM
To: Freed, Brian; Miller, Sharon
Cc: Aubrey, Michael; Fan, Yong
Subject: RE: BLA125391 - PI
Importance: High

 

Hi Brian, Sharon,

Please see further changes made by our team and address the comment in the PI.  Please respond back latest by 3:00 pm tomorrow.

Thanks,

Ramani

 

 

Thank you,

Ramani Sista, PhD, RAC
RPM
OCTGT/CBER/FDA
Phone: 301-827-5152

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please immediately notify the sender immediately by e-mail or phone.



--------------------------------------------------------------------------------

From: Freed, Brian [mailto:Brian.Freed@ucdenver.edu]
Sent: Saturday, May 19, 2012 8:38 PM
To: Sista, Ramani V; Miller, Sharon
Cc: Aubrey, Michael; Fan, Yong
Subject: RE: BLA125391 - PI

Dear Ramani,

 

I’m returning both documents, and I’ve accepted the tracked changes in both.  Although I suspect you only need the first one.  Thank you for all your help and the help of the clinical team. 

 

Brian M. Freed, Ph.D., DABHI

Professor of Medicine and Immunology

Executive Director, ClinImmune Labs

12635 E. Montview Blvd, Suite 300

Aurora, CO  80045

303-724-0535


From: Sista, Ramani V [mailto:Ramani.Sista@fda.hhs.gov]
Sent: Friday, May 18, 2012 11:44 AM
To: Freed, Brian; Miller, Sharon
Cc: Aubrey, Michael; Fan, Yong
Subject: BLA125391 - PI
Importance: High

 

Hi Sharon, Brian,

Please see attached PI tracked and clean version with our edits.  Please make your changes\edits in tracked and return the PI by noon Monday, EST.  We have one comment for you to address.

Do let us know if you have questions or need clarifications.

Thanks,

Ramani

 

 

Ramani Sista, PhD, RAC

Regulatory Project Manager

Office of Cellular Tissue & Gene Therapies

CBER, FDA

Phone: 301-827-5152

Fax: 301-827-9796

Ramani.Sista@fda.hhs.gov

 

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please immediately notify the sender immediately by e-mail or phone.