If they include 300mg dosing in their filing with the voucher then IF UNS/Sanofi are ready to be supplying/filling etc then a wearable could theoretically be on the shelf for us to buy in July-Sep. Even if UNS are only supplying limited numbers then they will most likely be used in strategic markets whilst everyone else makes do with two PFS or AID injections.
But I suspect that they would get the drug approved and then slip in the new devices with a sBLA. Amgen are doing it, Roche are doing it with their wearable. It is typical of risk adverse pharma where an issue is the reguators themselves not knowing what they want and changing expectations mid race
So, the question is did Daya Ranamukhaarachch coming on board 6 months ago ensure that everything is in order so that our wearable can be submitted with the Sanofi BLA filing?
I think you posted (or someone) that this is all just theory. We all talk about likes its a done deal but its speculation and there are certain pieces of the puzzle that don't fit and require some rather blind leaps of faith in their absence
UNS Price at posting:
77.5¢ Sentiment: None Disclosure: Held
