Yes, this is true. I assumed the poster was referring to the doctor’s office drawing the medication in the needle and providing it to the patient to take home (which may or may not be accurate). The question then becomes: what’s the approval process to sell a drug in a vial for home use injection where the patient draws the medication? Is there an approval process for this?

If I remember correctly, one of the recent breast cancer patients from Europe was sent home with leronlimab after being taught how to properly draw up and administer the medication. So it’s an option, BJJ it if it requires extra steps for the BLA at this time, I doubt CYDY will go this route. Sticking with the prefilled syringes commercial company seems like the most logical option.