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Re: pcinsurto post# 11378

Thursday, 05/21/2020 2:17:40 PM

Thursday, May 21, 2020 2:17:40 PM

Post# of 14942
I’m not understanding your “pull the plug” language. The filing has been rejected by the FDA for CMC issues. It was DOA. Now we need to get a Type A meeting, address the issues and resubmit. Right now the filing essentially doesn’t exist in FDA PROCESS
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