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Re: midastouch017 post# 3511

Wednesday, 04/28/2021 4:56:34 AM

Wednesday, April 28, 2021 4:56:34 AM

Post# of 3999
I feel like saying this makes no sense. And assuming this is a manufacturing site issue.

Why state that the original PDUFA was delayed due to not being able to visit the sites, when you are going to give a CRL, if the CRL was based on data that is.

So likely not a data issue. Balance superiority interim data out in 1-2 months.

The data clearly shows better safety, immunogenicity and efficacy in all trials to date. They gave it Accelerated Approval based on this, and then accepted the BLA data package and then based on that granted Priority Review. And then this??

Very strange.
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