RE: What exactly has changed?2 Nov 2021 10:14
Genuine question/discussion, up to you how you take this.?
Re it works in man.??so phase 1 is “normally” used to show safety, I think (no ideas to be honest, work with computers). Part of this is toxicology tests. Precision is aimed at lowering toxic effect esp on heart etc.??
So it’s a bit of a new case. Normally drug is tested to be safe at phase 1, and dosing is tuned, but Precision is claiming to be safer with same or better effects,, so phase 1 is a big part of total claims.??But given that toxic effects are lower at various dosages, doesn’t the trials then need to prove that the cancer treatment component is being delivered correctly and that patients are getting a better overall effect. It’s not enough to just show “it doesn’t kill anyone as fast”. Later phases must show that the cancer treatment part is released in tumour and works.
??I am not saying this the case is that the precision drug is not cleaved, but if that was the case the toxic effects would be ok but treatment would not work.??
What if patients were getting better and toxic effect were vastly reduced, could phase 1 be extended to keep treatment going until the tumour was reduced as far as possible in the patients that got it. That would seem to be ethical thing to do. Can this drug be given to those who have no option but palliative care and some last attempt if phase 1 is shown to be ok for toxicology.