“Although I think it's a pipe dream if you expect NP to wait for 30 patients. 5+ patients and he'll be driving to the FDA in person. :o).”
Hopefully NP learned his lesson from rushing the first BTD and having the application denied. He also tied an award of stock to that application, which I still find unwarranted.
Myself and a few investors here on IH did research last year into cancer BTDs. We found the fewest number of patients that a BTD was granted to was 40-50. NP mentioned the FDA said a minimum of of 15 patients would be sufficient, but I’m not a minimum kind of guy, so I’d prefer the entire phase 1b/2 be enrolled to 48 patients, wait 6 months, and then submit the application. Like Np said a few CCs ago, CYDY doesn’t need another “check mark” against the company (aka a 4th BTD denial).
Hopefully NP learned his lesson from rushing the first BTD and having the application denied. He also tied an award of stock to that application, which I still find unwarranted.
Myself and a few investors here on IH did research last year into cancer BTDs. We found the fewest number of patients that a BTD was granted to was 40-50. NP mentioned the FDA said a minimum of of 15 patients would be sufficient, but I’m not a minimum kind of guy, so I’d prefer the entire phase 1b/2 be enrolled to 48 patients, wait 6 months, and then submit the application. Like Np said a few CCs ago, CYDY doesn’t need another “check mark” against the company (aka a 4th BTD denial).
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