Liminal BioSciences Inc. PFSCF

FDA today's push

[HighteawithIntrepid]

Our STN: BL 125646/0

Novartis Pharmaceuticals Corporation Attention: Manisha Patel, PharmD
One Health Plaza, Bldg 315, Office 3450B East Hanover, NJ 07936

Dear Dr. Patel:

BLA APPROVAL

August 30, 2017

Please refer to your Biologics License Application (BLA) for tisagenlecleucel dated February 2, 2017, received February 2, 2017, submitted under section 351(a) of the Public Health Service Act (PHS Act).

We have approved your BLA for tisagenlecleucel effective this date. You are hereby authorized to introduce, or deliver for introduction into interstate commerce, tisagenlecleucel under your existing Department of Health and Human Services U.S. License No. 1244. Tisagenlecleucel is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of patients up to 25 years of age with B- cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. 

So SB there you go add about 60 days to the stated 120 and you get early October all things being equal for us. HT