Appreciate the response BJMK! With regards to r
Post# of 154909
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Posted On: 09/10/2020 9:53:45 PM
Appreciate the response BJMK!
With regards to refiling the HIV BLA I would be extremely elated if that were the case but I would think that Amarex is probably going to need some time to take what they learned from the written responses + the call on Tuesday to do the additional work. My guess is refiling the HIV BLA is probably months away not days, especially if we take the FDA up on their offer to look it over before submission (which as blafarm correctly pointed out is at least 30 days for them to do so).
You could very well be correct with the FDA wanting CD12 results before granting an EUA. If that is the case, I am optimistic that MHRA may be putting us through the process concurrently so that when the CD12 results are available we aren't starting the process at that point. I feel more confident that this is the case with the MHRA given the "pre-bla" materials we are proving them which include details about things like manufacturing. I think FDA is harder to gauge as NP hasn't given us anything other than them telling us a decision is "forthcoming"
Hopefully we will find out more next Wednesday! GLTU!
With regards to refiling the HIV BLA I would be extremely elated if that were the case but I would think that Amarex is probably going to need some time to take what they learned from the written responses + the call on Tuesday to do the additional work. My guess is refiling the HIV BLA is probably months away not days, especially if we take the FDA up on their offer to look it over before submission (which as blafarm correctly pointed out is at least 30 days for them to do so).
You could very well be correct with the FDA wanting CD12 results before granting an EUA. If that is the case, I am optimistic that MHRA may be putting us through the process concurrently so that when the CD12 results are available we aren't starting the process at that point. I feel more confident that this is the case with the MHRA given the "pre-bla" materials we are proving them which include details about things like manufacturing. I think FDA is harder to gauge as NP hasn't given us anything other than them telling us a decision is "forthcoming"
Hopefully we will find out more next Wednesday! GLTU!
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