Yes I agree, we need to take it one step at a time. I just thought that it would be good to highlight future risks with scaling manufacturing from clinical trial supplies to commercial supply.
I‘m sure their manufacturing via COH for the phase 1 trials is good right now - but they will need to revise that when they enter Phase 2 trials, hence, the hiring of Dr. Li Ren (VP Technical Operations). The FDA tightens up with manufacturing issues especially with cell therapy products so hopefully they can get this part right for Phase 2 onwards.
The acceleration of their clinical trial will definitely be dependent on the results of this phase 1, not just on the lack of SOC and new treatments. If you look at Paxalisib from Kazia Therapeutcs, they also target glioblastoma, but they have to go through the traditional route of Phase 3 trials. However, it is interesting that they are already planning for that Phase 2 registrational trial without any reporting of significant efficacy rates, which could be them hinting at us, that they are seeing early efficacy signals or they could just be banking on it just like us.
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