Great idea! Hopefully he will address some of the
Post# of 148187
I think wording these questions is important also. No one likes to feel attacked, so asking to-the-point direct questions in respectful ways goes a long way in receiving a better responses by establishing more effective communication and setting a tone (especially in written correspondence).
General: Feedback or sentiment from FDA on Leronlimab in HIV (combo, mono, PrEP), cancer (TNBC specifically), GvHD, etc.
Combo: Can you lay out combo BLA submission timeline to include FDA meeting of 525 vs 700, clinical portion based on both dose scenarios and CMO portion?
Mono: Will this be addressed during the combo meeting addressed above? If not, when do you anticipate this being complete and to begin enrollment. Can you lay out mono trial protocol (# patients, dose levels, random vs. targeted based on CCR5 occupancy test results, overlap/induction/maintenance periods) trial approval, expected enrollment and overall trial timeline?
I have to run, I will come back and ask some more when I get time.