The thing is, an EUA *can* be issued before Phase 3 trials are completed. Yet nobody seems to be talking about pursuing an EUA before Phase 3 trials are complete. It's a little confusing why they're not going for an EUA before Phase 3 trials are complete. Maybe the data just aren't compelling enough to try to push authorization through early.
Interesting, I didn't know that was an option. I suspect with all these delays from different companies that the companies are getting guidance from the FDA on what the FDA is looking for and the criteria are stringent enough to prevent approval without phase 3 data.
That would be my guess, too.
And as for issuing EUAs, for example, they gave EUAs to monoclonal antibodies by Eli Lilly and Regeneron in Nov. 2020 when Eli Lilly only had interim phase 2 results, and Regeneron hadn't even publicly released any results.
-18 after looking into this a bit more. Merck's Q2 earnings call document on page 9 says:
" We look forward to the readout from the Phase III portion of the study in the October timeframe"
Looks very unlikely before October 1.
The thing is, an EUA *can* be issued before Phase 3 trials are completed. Yet nobody seems to be talking about pursuing an EUA before Phase 3 trials are complete. It's a little confusing why they're not going for an EUA before Phase 3 trials are complete. Maybe the data just aren't compelling enough to try to push authorization through early.
Interesting, I didn't know that was an option. I suspect with all these delays from different companies that the companies are getting guidance from the FDA on what the FDA is looking for and the criteria are stringent enough to prevent approval without phase 3 data.
That would be my guess, too.
And as for issuing EUAs, for example, they gave EUAs to monoclonal antibodies by Eli Lilly and Regeneron in Nov. 2020 when Eli Lilly only had interim phase 2 results, and Regeneron hadn't even publicly released any results.
Interesting, that's useful to know!