Merck to start new trial on MK-7110 after FDA won'
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Posted On: 03/03/2021 2:23:54 PM
Merck to start new trial on MK-7110 after FDA won't act on a trial the DSMB halted for efficacy.
"It’s not that the agency wasn’t impressed by the data, because they were,” Kartsonis said in an interview. “They just want more of it, and more comfort that if we’re indeed going to bring this forward, that the data gets replicated.”
Goal post moving ticks me off, but I doubt this will impact us. While not previously approved, we are the "old school" candidate here - known manufacturing has been "rolling reviewed, safety record in 800 patients over multiple years, broad body of work in Covid (eINDs, two trials). How many other fusion proteins are out there in any application?
Lastly, the fact that Merck thinks it's worthwhile starting a Covid S/C trial that won't be over (approval) until 2022 clearly means we are not too late to the market.
https://www.bloomberg.com/news/articles/2021-...cquisition
"It’s not that the agency wasn’t impressed by the data, because they were,” Kartsonis said in an interview. “They just want more of it, and more comfort that if we’re indeed going to bring this forward, that the data gets replicated.”
Goal post moving ticks me off, but I doubt this will impact us. While not previously approved, we are the "old school" candidate here - known manufacturing has been "rolling reviewed, safety record in 800 patients over multiple years, broad body of work in Covid (eINDs, two trials). How many other fusion proteins are out there in any application?
Lastly, the fact that Merck thinks it's worthwhile starting a Covid S/C trial that won't be over (approval) until 2022 clearly means we are not too late to the market.
https://www.bloomberg.com/news/articles/2021-...cquisition
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