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IMGGorBust

07/15/10 1:05 PM

#19831 RE: IMGG4TP #19829

It has been reported here and on the Yahoo Board, and I believe the reports to be true, that in the latter half of April, Dean had a couple of telephone and email exchanges with the FDA Review Team regarding three very minor points -- two minor language changes to either the label or the manual and one request from the Review Team for a non-OCR final PDF version of the full application. Each of the three items was addressed immediately by Dean. I understand those communications to have been wrapped up around April 23 (someone else here can correct me if I'm off a few days).