m/m trial: 10 patients had score of zero, 30 patients were 4 or less
Seethamraju patients were extremely sick.
Agresti 4 patient results very impressive. critically ill, so much so that family was encouraged to say goodbye. all four patients received multiple other treatments and did not improve until given leronlimab.
Recknor: some of his patients were four weeks infected when they were dosed with leronlimab. He thinks leronlimab is indicated for mild/moderate who are long infected but who have not improved.
FDA EUA and MHRA fast track: both agencies want to see CD12 results. phase 3 will be needed for mild/moderate.
must provide MHRA with EIND details
DODy: update MHRA for covid, discuss covid reg path in UK. shared m/m results. MHRA recs early access meds, access prior to full authorization. the submission process has been initiated.
NP: phase 3 for moderate population, four weekly injections. sites ready to initiate.
kelly: longhaulers. some tipping point data??? blood brain barrier LL crosses in macaques. 70% receptor occupancy.
Recknor: new VP Clinical Development. cognitive fog in moderate patients who had symptoms for four weeks. "Marked" changes in cognitve on these patients. "Maybe this is post-viral".
NP: fastest path to covid approval is CD12 plus moderate plus long haulers
Dody: complete agreement with FDA as to what information needs to be provided for HIV BLA
Kelly NASH: approval for phase 2. mid to late november first patient injection and we will announce that patient injection when it happens.
Pourhassan: Immunomedics 21 billion acquisition.