One thing that bothers me is how unclear the HIV BLA situation is (To me). There has never been a clear explanation on what went wrong with the initial filing and what is being done to get it fixed. It started with syringes, format, dosage, receptor occupancy test…. To me, it is the main indication, we have hit our primary end point years ago and we still have not gotten it approved. This is not a domain I am knowledgeable about but it should have been given priority. It is the closest indication to generate revenue. Revenue to fund other indications.
Since the refuse to file letter over a year ago, I am having hard time understanding why it is taking so long, and why we don’t have an estimated time to get if filed. Just filed.
I know It will happen, it has to. It is taking longer than we wished for, but good things happen to those who wait.