Pete - there may be a 3-4 cohort space between the
Post# of 72440
Pete - there may be a 3-4 cohort space between therapeutic levels and mtd. We'll see. Preclinicals can't predict cohort number. If anyone told you that - they made it up.
Preclinicals can't mimic the activity of a liver human enzyme system - so drugs that look great in preclinical often do surprising things in real people. And...this often doesn't show up until phII - when people are treated at therapeutic dose for designated time. That is when liver problems - perhaps the most common reason for trial failure - most often show up. Not in PhI...
So - ctix already has their phII outlines written. They'll get green light from fda when they supply the safety data from this trial in a cohesive write-up - and then they'll go. FDA can give approval in just a few weeks - they're much faster at responding than they used to be. If ctix has already recruited research hospitals - perhaps df has consented to do a phII - they can get started within within weeks of approval. But the start is the tedious process of recruitment and prescreening for eligibility and informed consents, etc...That part will be invisible to us and will take a while. We'll be sitting here asking "when will they start" when the recruitment means they already have....