(Total Views: 761)
Posted On: 06/07/2020 2:56:33 PM
Post# of 155727
Re: LaundryMoney #36966
“NP says "we are now going to meet with the FDA for breakthrough designation.”
The meeting NP is referring to is only a pre-BTD meeting, not a meeting to get BTD granted. The first BTD application was basically denied but the FDA, according to NP, told CYDY to request a pre-BTD meeting to get guidance from the FDA on what the FDA would like to see in the next BTD packet. Per the PR from April 3rd, “Last month, the Company reported that the FDA had recommended such a meeting to provide preliminary advice prior to resubmission of a Breakthrough Therapy designation request.”
IMO, I don’t think BTD will be granted at this meeting, especially given the delays in the cancer trials due to COVID19, but the FDA will hopefully give clear guidance on how many patients worth of data they’d like in the next request.
The meeting NP is referring to is only a pre-BTD meeting, not a meeting to get BTD granted. The first BTD application was basically denied but the FDA, according to NP, told CYDY to request a pre-BTD meeting to get guidance from the FDA on what the FDA would like to see in the next BTD packet. Per the PR from April 3rd, “Last month, the Company reported that the FDA had recommended such a meeting to provide preliminary advice prior to resubmission of a Breakthrough Therapy designation request.”
IMO, I don’t think BTD will be granted at this meeting, especially given the delays in the cancer trials due to COVID19, but the FDA will hopefully give clear guidance on how many patients worth of data they’d like in the next request.
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