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Posted On: 06/01/2020 4:24:23 PM
Post# of 154026
“It is definitely possible to request priority review when submitting the BLA/NDA.”
CYDY and Amarex we’re struggling to just complete the BLA. NP mentioned at one point that they’d work 24/7 until the BLA was finished and ready for submission. Then, after it was submitted, they still had to submit further data the FDA asked for.
Given the above, do you think CYDY/Amarex could’ve completed the Priority Review packet at the same time as the BLA? Probably not. And if they did, the BLA would’ve been delayed further. One way or the other, the BLA for combo is where it is at right now, so discussing what’s could’ve been done is like stating the BLA was suppose to be submitted in November, December, etc. It’s a waste of time.
CYDY and Amarex we’re struggling to just complete the BLA. NP mentioned at one point that they’d work 24/7 until the BLA was finished and ready for submission. Then, after it was submitted, they still had to submit further data the FDA asked for.
Given the above, do you think CYDY/Amarex could’ve completed the Priority Review packet at the same time as the BLA? Probably not. And if they did, the BLA would’ve been delayed further. One way or the other, the BLA for combo is where it is at right now, so discussing what’s could’ve been done is like stating the BLA was suppose to be submitted in November, December, etc. It’s a waste of time.
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