Tuesday, May 18, 2010 5:01:07 PM
I have one additional question for your list:
“Dean, did the FDA’s 30-day response timeframe reset when you submitted new information on Friday, April 23rd?
I ask this question based on a recent comment from a Dr. Polk on the Yahoo IMGG message board who wrote:
“…As stated earlier, numerous times, the last request for a change in 2 sentences and a format change was submitted 4/23. Look at your calendars. Sometime this week will be 30 days since submittal of such…”
If he’s correct, then the FDA’s 30-day response time could be 30 days from Monday, April 26th,, i.e., on Tuesday, May 25th.
Then, allowing 3-4 days for the written communication to reach IMGG, one might expect an announcement of the FDA’s decision on or around Monday, May 31st.
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