Biotech Values

[poorgradstudent]

>I believe that SNY is arguing that this kind of "comparative assessment" is prohibited by FDA statutes.<

Do we know that the data submitted by MNTA pertained to their product only? Seems to me that the way for MNTA to do these comparisons is to check their product versus commercially available Lovenox. Otherwise, they would not be able to say "our generic product X is within the range demonstrated by brand drug Y."

If all the data submitted to the FDA were provided by MNTA, then it wouldn't be a breach of anything.