has informed Biogen that the FDA will not complete its review of Tysabri risk factors which includes the JCV antibody test.
Biogen submitted its application in December 2010, it was expected to be reviewed by September 2011. The fda has informed biogen they will need an extension of about 3 months to determine how the additional risk factors will be incorporated into the REMS program,Risk Mitigating Program.(ie. REM has the Touch program with 6 months appointment with neuro required)
interesting...it sounds as in January we will have many questions answered...not just approval of the jcv test but how often and stuff like that. keep you fingers crossed. answers would be nice!
Biogen submitted its application in December 2010, it was expected to be reviewed by September 2011. The fda has informed biogen they will need an extension of about 3 months to determine how the additional risk factors will be incorporated into the REMS program,Risk Mitigating Program.(ie. REM has the Touch program with 6 months appointment with neuro required)
interesting...it sounds as in January we will have many questions answered...not just approval of the jcv test but how often and stuff like that. keep you fingers crossed. answers would be nice!