PAA 2.33% 21.0¢ pharmaust limited

I think it's already been mentioned, but when we were...

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    I think it's already been mentioned, but when we were anticipating BOT's FDA approval for Sofdra last year, the FDA went down to the very last day of the 6 month process to send a CRL to BOT, and the only fault they found in the drug application was that the written instructions weren't detailed enough (no issues with the science). So it took 6 months to let BOT know they needed to include "wash hands before use" on the instructions and packaging, and some other minimal detail. So yes, the FDA is a government bureaucracy that isn't interested in bringing forward anybody's approval - they've got a maximum timeline and they'll use every minute of it.
 
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