Could well be Joe.
See except from capital raising presentation 21 June 2021. No updates on AIPAC P3 trial since.
Marc may be awaiting final OS data results (SITC - Nov) this time - as some may remember a small registrational trial was planned pre AIPAC PFS readout early last year. Didn't happen due to non-statistical benefit data v chemo.
OS data (especially in 2 sub-sets) has significantly improved chances of efti in combo with chemo becoming a SOC within 2-3 years.
Very rare for a small biotech to take a drug all the way through a P3 trial (500 patients - median cost per patient $50k US).
IMO - wont happen. Enter BMS stage left and possibly Merck stage right???
Post Transaction - Funded to Q4 20231
❑ Phase III Registrational Trial: in Metastatic Breast
Cancer (based on AIPAC).
❑ with 500 patients
❑ 90% power, alpha=0.05 and HR <= 0.7
❑ Overall Survival primary endpoint
❑ Phase II Trial: NSCLC
❑ 80 patients to test e.g. anti-PD1 + chemo + efti
combination
❑ 2* IITs with up to 40 pts each
❑ Commence process characterization and process
validation for efti commercial manufacturing
❑ Regulatory interactions with FDA and EMA
❑ IMP761: IND package
❑ Increase of staff and other operational costs
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Could well be Joe. See except from capital raising presentation...
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