Post by
Duster340 on Feb 03, 2021 9:04am
If declining covid trend continues?
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. With this situation expected to ease later in the year as vaccines take hold, guidance for trial initiation is being adjusted to the second half of 2021
Comment by
Scrivs187 on Feb 03, 2021 9:44am
nvm, disregard last. Put them in the same post