Goose, your quote on the rolling review of BLA: "
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Posted On: 05/04/2021 11:10:30 AM
Re: Goosebumps #88931
Goose, your quote on the rolling review of BLA:
"My understanding is we could of filed section by section and sought guidance as we went along. Being a fledgling biotech you would think that would of been the way of choice. To have the FDA evaluate each section as it is completed and correct those that are not properly formatted or missing the needed information."
Goose, maybe I've been here to long to remember but I remember that CYDY did actually file a rolling review for HIV way back and that CYDY had submitted the first 2 parts of the 3 parts and that is where we got stuck.
I am not sure on your quote above so someone correct ME, if I'm wrong.
Whether we are refiling for the rolling review again, I am dumb founded if we are as we did over a year ago file that RR. Egads, am I really here to long? I digress - GLTU
HCIT
"My understanding is we could of filed section by section and sought guidance as we went along. Being a fledgling biotech you would think that would of been the way of choice. To have the FDA evaluate each section as it is completed and correct those that are not properly formatted or missing the needed information."
Goose, maybe I've been here to long to remember but I remember that CYDY did actually file a rolling review for HIV way back and that CYDY had submitted the first 2 parts of the 3 parts and that is where we got stuck.
I am not sure on your quote above so someone correct ME, if I'm wrong.
Whether we are refiling for the rolling review again, I am dumb founded if we are as we did over a year ago file that RR. Egads, am I really here to long? I digress - GLTU
HCIT
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