With the corruption in BP and FDA, as much as I want a BLA, I don't see it happening. With no corruption, I could barely see it with what we have. With corruption zero chance. He'll, I just hope with our new strategy BP and the FDA will let us get to market with a partner. I would love to be wrong.
Yes, it sure looks astronomical....or not. Probably not based on every trial to date except mice. If you can cure mice, you are in the wrong business...
Does MRK prove the truth of the statement that, if you can have[or already have] the initial ability to pre-select the correct patient to treat[e.g., a patient with enough targets to hit with your company's I-O therapy], the company having that initial ability will achieve a better share of successful treatments:
"... Patients enrolled were those who had received no prior systemic chemotherapy treatment for their advanced disease and whose tumors expressed high levels of PD-L1 (defined as a tumor proportion score of 50 percent or more) as determined by a central laboratory using an immunohistochemistry assay...."
Failing that initial ability, Keytruda still likely fails treatment purpose because of low RRRs, w/o assistance from somewhere to overcome those patients' disadvantage.