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Re: JB3729 post# 660

Sunday, 12/29/2019 9:51:51 AM

Sunday, December 29, 2019 9:51:51 AM

Post# of 1121
“ Also, VC has done an outcome trial and CP has not. But the thinking is that FDA may start to look at N-3 drugs as a class, especially if the upcoming STRENGTH trial data from AstraZeneca is good, as I believe it will be.”

This is an interesting observation.
ACST is doing 2nd follow up trial and it’s topline results will come in 4-6 weeks after 1st trial.

Question - if results from both the trials are very good - will it allow them to file NDA or as none of the trials are announced as pivotal, will they need to conduct another larger trial? Or they will need to carry an outcome trial like VC and it will be long duration.
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