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Posted On: 03/11/2020 6:06:04 PM
Post# of 153941
“Okay FDA, just approved the IND.”
This was not said in the interview. I’m assuming you’re busy today as typically you’re postings are very accurate. CYDY will will publish a PR the second the FDA approved the IND.
NP said the FDA responded and asked for a pre-IND call with the CYDY. Hopefully that will happen soon. He didn’t give a timeline.
In regards to the BLA, the FDA has still NOT indicated which dose they want. I’m not sure how this simple process can be so hard for the FDA. But NP said they expect to have the BLA submitted by the end of March because the clinical and manufacturing portions are ready.
This was not said in the interview. I’m assuming you’re busy today as typically you’re postings are very accurate. CYDY will will publish a PR the second the FDA approved the IND.
NP said the FDA responded and asked for a pre-IND call with the CYDY. Hopefully that will happen soon. He didn’t give a timeline.
In regards to the BLA, the FDA has still NOT indicated which dose they want. I’m not sure how this simple process can be so hard for the FDA. But NP said they expect to have the BLA submitted by the end of March because the clinical and manufacturing portions are ready.
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