why would you talk to the fda unless you knew something that would require fda review/approval?
my bet guess is the results now show permanent pain reduction at 12 week or so as opposed to the original pain reduction at 6 weeks as reported; the pain free effect is long lasting
"We believe the next steps for AQX-1125 in BPS/IC include finalizing our pivotal trial designs in consultation with the appropriate regulatory authorities, including the FDA and EMA, to set a path to potential approval," added Mr. Main.
More relevant to you on the call today is our intent to hold a research day in New York in early October with our team and an independent key opinion leader in attendance. The purpose of this event will be to review the current state of BPS/IC, our LEADERSHIP full results, as well as discuss our proposed pivotal trial program.
The specific date and location has not yet been set, but we will communicate this as soon as that information is available. And of course, we hope that those of you in New York City can participate in person, while a webcast will be available for everyone else
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