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dennisdave

01/05/22 10:33 AM

#432177 RE: antihama #432174

So the whole point of my post is to concur w you that a BLA has not been submitted yet



But I do hope they have used their time wisely since data lock and at least drafted the BLA for a large part. I mean what else could they have been doing? The publication is out of their hands so other than watching Netflix I do hope they hope they have been working on BLA.
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newman2021

01/05/22 10:54 AM

#432187 RE: antihama #432174

I don't agree with either of you. I believe a BLA has already been submitted and (label) negotiation is on going, imo. Recall DI said seeking approval has nothing to do with the publication; they are separate track by themselves. He also said the Company is determined to take the DcvaxL to the patients. He said both of these statements some 6 months ago. And almost around the same time we saw an 8K saying they were working on putting together a BLA. Wish I am right and God's willing an approval will answer all our prayers, imo.