Ann: MAYNE PHARMA provides FDA update on generic NUVARING, page-31

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doubledeckerdog

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08/10/21

07:26

Post #: 56648825
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Originally posted by Patrick31: ↑

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 ..

Expand

The reputation has been earned by repeated errors and a complete failure to generate value for shareholders.
The only winners have been board and execs on the gravy train.
Chuck 'em out and start again!!!
I know the clean out has started but leaving the CEO in place is a disaster given past form!!
DDD

MYX Price at posting: 31.5¢ Sentiment: Sell Disclosure: Not Held
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Ann: MAYNE PHARMA provides FDA update on generic NUVARING, page-31

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