GREY:ATBPF - Post by User
Comment by
Duster340on Apr 01, 2021 12:44am
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Post# 32920664
RE:Article ind
RE:Article ind Duster340 Writes:
Otenaproxesul’s Phase III preparations remain on schedule. With eight Phase III-enabling animal studies finished and a further two to complete (these are in canada) As planned, we will be submitting otenaproxesul’s IND (“Investigational New Drug”) application to the U.S. FDA within weeks. In ordinary circumstances, we would then expect to proceed with the adaptive Phase III trial in the upcoming quarter. However, the ongoing rise in COVID-19 infections is increasingly compromising the ability of clinics and hospitals to accommodate large clinical trials, particularly in the U.S. where this trial must take place.