That BLA lit­tle Am­pio promised? That’s not go­ing any­where as FDA slap-down trig­gers an ug­ly rout

Sev­en months af­ter Am­pio Phar­ma­ceu­ti­cals $AMPE gave its long-suf­fer­ing in­vestors some­thing to cheer about with their re­port that a third try at a piv­otal study for their os­teoarthri­tis drug had rung up pos­i­tive, clear­ing the way to an FDA ap­pli­ca­tion, it’s time for an­oth­er cru­el set­back.

The lit­tle En­gle­wood, CO-based biotech re­port­ed in an SEC fil­ing that reg­u­la­tors didn’t ex­act­ly agree that it had two well-con­trolled stud­ies to re­ly on for its ap­pli­ca­tion, and sent the ex­ec­u­tive team pack­ing with in­struc­tions to do yet an­oth­er Phase III if they ex­pect to ever win ap­proval.

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