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Posted On: 06/01/2020 12:30:53 PM
Post# of 149229
Re: craigakess #36117
“Remember how we were supposed to hear about BTD in April (60 days after filing)? Yeah, that went out the window.”
CYDY did hear back from the FDA and the FDA basically denied the BTD application and gave further guidance (set up a pre-BTD meeting to discuss what the FDA would like to see in terms of number of patients). I don’t remember when NP specifically discussed this, but it was mid to end of April.
IMO. NP knew the BTD was denied within the 60 day window but was trying to get further guidance from the FDA on the path forward in order to make the denial look less like a straight “No”.
CYDY did hear back from the FDA and the FDA basically denied the BTD application and gave further guidance (set up a pre-BTD meeting to discuss what the FDA would like to see in terms of number of patients). I don’t remember when NP specifically discussed this, but it was mid to end of April.
IMO. NP knew the BTD was denied within the 60 day window but was trying to get further guidance from the FDA on the path forward in order to make the denial look less like a straight “No”.
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