(Total Views: 408)
Posted On: 03/02/2020 8:02:05 PM
Post# of 149070
“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.
(1)
(0)Scroll down for more posts ▼
