That discussion may be interesting but unlikely to

That discussion may be interesting but unlikely to be reality. If the combo trial was standalone then it would be possible to retrieve raw data from the study sites for the 52 patients. But any approval was also predicated on safety data from the monotherapy trial. The FDA would be willing to lift the hold based on existing safety data properly presented but highly unlikely to revisit an approval based on that. The FDA is not going to ask for a new HIV protocol only then to approve a resubmitted BLA.

My guess is that the FDA would be willing to accept a protocol with 150-200 patients in combo therapy with the trial lasting one year. Then solely base their decision for approval on the data from that trial.