Tuesday, September 26, 2023 11:30:39 AM
“Once we did the insufflation study, we are resourced because the results were positive and we wanted to make an announcement. But then we learned that there are three other companies that are doing the same thing and we did not want them to beat us to the punch by knowing that we just made an announcement that we're going to file. So we had to be quiet, wait till we file a partial application to get the PDUFA date going, okay? And now I can tell you about it. The full application should be filed by August 1st and hopefully the FDA would accept it. That usually takes 45 to 60 days and once they do, we'll make an announcement. “
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