Biotech Values

[dewophile]

so it seems that the 5 criteria were already put forth as early as 2004

Beginning in 2004, scientists at FDA’s Office of New Drug Quality
Assessment (ONDQA) expressed their disagreement with OGD’s five-criteria approach

this blows a hole in the entire argument that MNTA essentially helped draft the criteria for approval of lovenox

imo that leaves only immunogenicity and supply chain issues as obstacles for amphastar, and presumably only immunogenicity for teva

immunongenicity may remain a difficult hurdle, but this does increase the odds of an eventual teva (and even amphastar) approval imo