“One way around this is to drop any copackaged syringe/needle from approval package, let docs use their own. This means CYDY will ahve just the vial. So this is easily correctable. No absolute need to have a "kit" of the vial + syringes.”

This is a big flaw in this poster’s plan and absolutely not a solution that CYDY will consider. CYDY’s goal with leronlimab for HIV, at this time, is that the drug is a once a week subq injection that can be completed at home. In order for this to be reality, the syringes need to be prefilled with the proper medication dose and dispersed to the patient at the pharmacy. Depending on how often the patient needs follow up, the doctor may prescribe 6 months worth at a time. With that being said, doctor’s offices around the country, and eventually around the world, aren’t going to individually fill each syringe for the patient and then send the patient home with those syringes. In most clinics, syringes with medication drawn in the clinic cannot leave the clinic grounds and are only for administration in the clinic by a trained medical professional.

This is not an option.