Reinstating phase1b was the spanner in the wheels3 Mar 2024 13:05
To all,
Remember last year when they announced they would remove and replace phase 1b by the short bi-weekly study, resulting in an expedited timeline and resulting cost reduction? Looking at the Turner Pope graph, they sneakily did call it "Dose expansion into phase 2". A few milestones:
- Q4-2024: Phase 2 Expansion cohorts (this is where dose escalation phase starts --> typically called phase 1b)
- Q2-2025: Selection final Phase 2 Indication (this is where the real phase 2 starts)
- Q2-2025: Final Phase 1 data (not Phase 1a, but Phase 1... incorporating Phase 1b - dose escalation) & AACR for AVA6000 Phase 1 (2w and 3w)
SO WHAT HAPPENED:
- They did not get clearance to remove Phase 1b by FDA
- Next to the newly instated bi-weekly dosing, they had to reinstate Phase 1b
- Resulting timelines slipped to even more than before (not just Phase 1b, but on 2 weekly dosing study)
- Ongoing commercial discussions based on reduced timeline and solid cash position now compromised since a year added and avacta not having the contingency cash to absorb
- RESULT: Scramble for cash to cover extended timeline and addition of Phase 1b
MY POSITION:
- as long as the science keeps delivering, I stay put. the addition of bi-weekly dosing on top of Phase 1b might prove to be a blessing in disguise if it proves to improve effectivity.
My two cents