research reports and media, page-4246

TR
There in lies the problem all this DATA, the data is all over the shop various studies in various diseases at various dosing regimes, the FDA don't like it like that. They like one condition one dosing regime or a regime that escalates with various doses to prove safety and efficacy till OBD is reached, when that is found a trail to prove it works in larger cohort.

To me they have wasted to much $ and trialed to many conditions and although the drug obviously works in various parts of the body probably more than we will ever know. That is not what FDA want. Do one when approved money comes in then move to next one.
The big boys do one condition then when that gets over the line move on to other conditions. I am not sure what they submitted but if it is various conditions to prove safety FDA don't like that all too hard to broad. Keytruda and Humira as examples.
All IMO