“While I don't love potentially restarting the 6
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Posted On: 03/02/2020 8:02:05 PM
“While I don't love potentially restarting the 60 day period, I do love the notion that five great sets of data will almost ensure FDA approval.”
Personally, I hope the FDA restarts the 60 day period so CYDY can provide data from more patients. Like I’ve said before, I believe CYDY submitted the BTD too soon and should’ve waited for data from at least 5 patients, if not more. NP initially said they’d wait for data from 5-10 patients to file for BTD, but I think the results from patients #1 and #2 got him excited. The more data the better.
I believe someone said that CYDY can apply for BTD again if this first one is denied, so I’m not too concerned if that statement is true.
Personally, I hope the FDA restarts the 60 day period so CYDY can provide data from more patients. Like I’ve said before, I believe CYDY submitted the BTD too soon and should’ve waited for data from at least 5 patients, if not more. NP initially said they’d wait for data from 5-10 patients to file for BTD, but I think the results from patients #1 and #2 got him excited. The more data the better.
I believe someone said that CYDY can apply for BTD again if this first one is denied, so I’m not too concerned if that statement is true.
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