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Posted On: 06/25/2020 2:13:26 AM
Post# of 154091
Re: Goosebumps #39074
Goose -
April 27th was the date of the filing. On May 11th they answered some clinical data questions, and later they answered some manufacturing questions. Those responses didn't alter the April 27th date of filing. That makes the July 10th date (mentioned by NP) the 74 day letter and June 26th the 60th day.
Too bad you view my comment as claiming the sky may fall - all I'm telling you is the procedure: on day 60 the FDA sends (a) a refuse to file notice, (b) a priority review notice, or (c) nothing. That's the official procedure - I can't be sure they will follow it.
April 27th was the date of the filing. On May 11th they answered some clinical data questions, and later they answered some manufacturing questions. Those responses didn't alter the April 27th date of filing. That makes the July 10th date (mentioned by NP) the 74 day letter and June 26th the 60th day.
Too bad you view my comment as claiming the sky may fall - all I'm telling you is the procedure: on day 60 the FDA sends (a) a refuse to file notice, (b) a priority review notice, or (c) nothing. That's the official procedure - I can't be sure they will follow it.
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