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Posted On: 03/20/2020 3:50:48 PM
Post# of 36567
Regarding the Regentys Ulcerative Colitis gel:
"The FDA has affirmed our approach to file a 510(k) de novo application on its ECM hydrogel. We have developed a protocol and has engaged a clinical research organization to manage the conduct of its first-in-human clinical trials expected to start in Q2/Q3 2020 in Australia."
I assume those are fiscal Qs, so that would mean by end of April...
"The FDA has affirmed our approach to file a 510(k) de novo application on its ECM hydrogel. We have developed a protocol and has engaged a clinical research organization to manage the conduct of its first-in-human clinical trials expected to start in Q2/Q3 2020 in Australia."
I assume those are fiscal Qs, so that would mean by end of April...
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