Yes , for FDA knowing for over 5 years safety of our product is sometimes unexplainable how they delay all
, and what they asking for .,

I still can’t forget that MDR HIV patients are dying , and after so many years we not approved .,
I be very interested to see how long after BLA will be submitted , approval will come .,,

But , this is a system and look that we can’t change it .,
I am sure that at times it is saving life’s , but often is tragic other way ..

All imo