RISPOSTE DI VALEANT:
We do not as yet have a timeframe but we have been working on the observations already and submitting our progress
to the FDA. Hopefully a small delay.
ven. 22/07/2016 15:35
ma question
Hello, Can you provide further explanation of the problems associated with the manufacture of latanoprostene BUNOD.
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deep27 19:05 - 23.07.2016 3
As we said in the press release, we will be meeting with the FDA to discuss further. We do not have a timeframe as yet,
but we are, and have been, working to satisfy the observations made by the FDA for the Tampa plant. Plants are
inspected all the time and just like any inspection, the FDA can request changes to be made. Product continues to made
in the plant and distributed to the market, so none of the observations were severe. As soon as we know a timeframe, we
will disclose, but we are working to fix the issue as soon as possible.
Ma possiamo fidarci delle risposte di Valeant ?