I can't help but think the FDA's initial reaction
Post# of 148113
Quote:
I can't help but think the FDA's initial reaction would be HELL NO. Stick to what we agreeed on. There would have to be a great reason for me(FDA) to say ok, sounds good, go ahead.
There is a good rationale behind leronlimab's use in mCRC and we've already had trials that show what it can do in cancer generally. There are no safety issues. With those criteria established the FDA have no say in which trials we wish to proceed with.