chart daily, page-2221

Goise

certainly, just as MM stated in the interview. They will be doing everything to get the 'outside US' trial underway asap.

We might ask why they would be doing such a trial when an FDA sponsored one is obviously the ultimate goal. My view is that it is precisely because they can arrange and perform it very quickly, whereas the FDA require time to make an assessment and give the go ahead. The Americans will be making assessments as quickly as possible, but 225 is not the only drug candidate in their inbox. The assessment is not going to occur overnight, and for this reason I suggest the outside US trial is being conducted for easier expediency.

I know MM referred to this trial using language like, '5 days,' and the BIT225 dosing may take only that small amount of time, as it was for the mice, in which case trial results will come quickly too. I'm seeing that the data from the outside US trial is going to compliment the FDA assessment, so this would even bring more urgency for it to occur asap.

I've mentioned previously that I thought it would be conducted in Australia, but it could be anywhere, somewhere where the formalities are expedient, and the patients available. Maybe even Omicron will have some influence.

Anyway, not long now.