(Total Views: 710)
Posted On: 08/21/2020 11:42:57 PM
Post# of 155813
10blade posted:
I'm having difficulty following the logic of this post:
1. To my knowledge we have not received a CRL
2. How does receiving a refusal to file letter for the BLA regarding HIV effect our ability to file for EUA on a totally different study investigating a different indication?
#1: Yes, my mistake, it was an RTF not a CRL. I went back and edited after CDiddy pointed it out.
#2. Trying an end run on HIV sends the message "Quit messing with us". Seems to me to indicate frustration with the FDA's actions on HIV.
"Quit messing with us" is further emphasized by filing UK covid EUA before FDA decides on US covid EUA. Giving UK the chance to EUA before the FDA dispositions is clearly a "Quit messing with us" move.
I'm having difficulty following the logic of this post:
1. To my knowledge we have not received a CRL
2. How does receiving a refusal to file letter for the BLA regarding HIV effect our ability to file for EUA on a totally different study investigating a different indication?
#1: Yes, my mistake, it was an RTF not a CRL. I went back and edited after CDiddy pointed it out.
#2. Trying an end run on HIV sends the message "Quit messing with us". Seems to me to indicate frustration with the FDA's actions on HIV.
"Quit messing with us" is further emphasized by filing UK covid EUA before FDA decides on US covid EUA. Giving UK the chance to EUA before the FDA dispositions is clearly a "Quit messing with us" move.
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