Biotech Values

[north40000]

"If the proposed trial is one-up[sic: one,] against an approved therapy, then I could see the FDA showing more interest in whether there were plausible signs of efficacy."[I did not understand meaning of one-up, sounded like a tennis match or baseball game]

Has that not occurred with PPHM's Phase III trial? Your 2 "if" examples cover PPHM phase 3 trial in either alternative.