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Posted On: 03/27/2019 11:05:17 AM
Post# of 72441
BooDog from the boss when asked about 45 days for EMA request.
"Our request is for guidance so we can have coordinated trials meeting US and EU regulations. Yes, we expect to interact with the EMA shortly as per our filing and having met the requirements necessary for this guidance. I can't pin a date as I have never gone through this process but our regulatory consultants advise us we are all set."
"Our request is for guidance so we can have coordinated trials meeting US and EU regulations. Yes, we expect to interact with the EMA shortly as per our filing and having met the requirements necessary for this guidance. I can't pin a date as I have never gone through this process but our regulatory consultants advise us we are all set."
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