Wednesday, July 26, 2017 5:57:27 PM
If the committee don't agree Rexista should be approved, it's going to be very hard for IPCI to get it through FDA. It would be up to IPCI to get an agreement with FDA to clear the path for approval. I am sure management will meet with FDA to try and secure approval.
Our only hope is that FDA require additional trials and agree to approval on meeting their guidelines and conditions set forth in the meeting.
However, if during the meeting FDA says no, we will not approve Rexista in its current conditions, then we're in trouble and it would means that Odidi will need to go back to the lab and come up with a different way to prevent nasal abuse.
Run any necessary trials and resubmit the application.
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