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Posted On: 07/13/2020 1:29:48 PM
Post# of 148902
“Agreed that there needs to be more precision in statements. There should be a good account of the BLA PDUFA issue.”
Dr. Kelly, the scientific advisors, and the lawyers need to reel NP in on this issue. He constantly misspeaks, not because of the language barrier or his accent (as some would claim), but because he isn’t medical and often confuses medical trial information, requirements, etc.
Now, would that change the fact that the BLA was returned? Probably not, but possibly. I believe NP presses the company in the same manner that he makes comments and likely was pressing BLA submission.
Like you said, we’ll see what the CC holds. The good news is the FDA isn’t asking for another trial, but further analysis of the data (according to the PR). That still concerns me, but we’ll see what NP and company have to say.
Dr. Kelly, the scientific advisors, and the lawyers need to reel NP in on this issue. He constantly misspeaks, not because of the language barrier or his accent (as some would claim), but because he isn’t medical and often confuses medical trial information, requirements, etc.
Now, would that change the fact that the BLA was returned? Probably not, but possibly. I believe NP presses the company in the same manner that he makes comments and likely was pressing BLA submission.
Like you said, we’ll see what the CC holds. The good news is the FDA isn’t asking for another trial, but further analysis of the data (according to the PR). That still concerns me, but we’ll see what NP and company have to say.
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