RE: What I would love to see minimum27 Mar 2025 10:12
Good summary HBD.
I have two follow up questions.
How are we able to tweak the formula? Surely the formula is set in stone, has been written extensively in multiple patents (IE. Set in stone) and should be the exact same formula throughout phase 1, 2 and 3.
If we change it, does it slightly invalidate results from phase 1 trials?
2. Why are we intentionally making the capsule/tablet/recipe dirty? I absolutely do not understand a "need" to find tox side effects.
If we are clean and safe at 100migs, great. If we are clean at 150mg, great. I have never heard of making a batch "dirty" before. Is there precedent for this?
Related to this, John or Tim stated this batch for the tox studies will be dirtier than ones we use in patients.
What is the point in using different batches? Aren't we doing our excellent molecule a disservice by making it worse? Why don't they just send some baricitinib if we're tweaking it and making it worse...?
It doesn't make any sense to me to use a dirty batch now, then a clean one in patients. But hey ho, I have to believe this is:
A) how things are done
B) Tim and John know what they're doing.
I don't see why we can't just up the migs to get 200mg effects, 300mg effects, 400, 500mg etc. Etc. Until we find some adverse effects.
Surely going higher and saying "WE ARE SAFE UP TO 600MG" would be better than saying we're safe at 50mg, unless you're taking a dirty batch...in which case it might not be...