the pre-IND meeting with the FDA was completed June 2020. over...

the pre-IND meeting with the FDA was completed June 2020. over 14 months later they still do not have an active IND and cannot begin the trial until they do. my guess is that FDA asked them to complete a slew of pre-clinical assays at that pre-IND meeting before they file and they might be having issues completing them.

IMO if they are using bioMUSE as an excuse to delay the start of the trial we are probably screwed for another 6 to 8 months. ph2 is...or was the last time i heard, an adaptive trial design. so they can start the study before all the bioMUSE data is in and adjust endpoints and biomarkers as new data comes in. it seems though they are being very slow and conservative and will not start the trial until bioMUSE gives them what they want????