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Posted On: 02/26/2025 9:14:49 PM
Post# of 150676
Amarex data was a major issue in 2022, you are correct. They could have gotten more insight into Amarex after the lawsuit.
I don’t want to confuse you or even more.
Simply OHM is right. As far as I’m aware the BLA is definitely dead. Until the company says otherwise which they probably won’t. It’s dead.
Playing devils advocate. Anything is possible but we have no proof they plan on filing it again.
I will say an approval goes beyond MDR pop the value is so much more than just this. It’s beyond that. I mean Samsung doesn’t get paid without an approval. The list can go on. How long do they plan on waiting.
I think all of this, is to address the FDAs concerns for upcoming trials and not the BLA until told otherwise.
I don’t want to confuse you or even more.
Simply OHM is right. As far as I’m aware the BLA is definitely dead. Until the company says otherwise which they probably won’t. It’s dead.
Playing devils advocate. Anything is possible but we have no proof they plan on filing it again.
I will say an approval goes beyond MDR pop the value is so much more than just this. It’s beyond that. I mean Samsung doesn’t get paid without an approval. The list can go on. How long do they plan on waiting.
I think all of this, is to address the FDAs concerns for upcoming trials and not the BLA until told otherwise.
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