Ann: MAYNE PHARMA provides FDA update on generic NUVARING, page-29

After having a little research on CRL
from FDA . It appears there are 2 categories
1 is a two month assessment
2 is a six month assessment.
The majority of approval failures are to do
with efficacy and safety not manufacturing etc.
Since this will be Maynes 3rd resubmission
mine would think they would have learnt.
Just because the FDA don’t raise issues
with them doesn’t mean they are ok in that
area. Obviously like giving the answers to
questions prior to the exam.
I wish Mayne would stop repeating how they
are working closely with FDA.
They along with Mithra are gaining a reputation
as Pharmaceutical Nincompoops ..