Replies to post #62018 on Biotech Values

[stockdak]

Thanks for your response Dew.
I agree with your assessment of MNTA's expertise which includes the software used to analyze the data and the proper application of enzymes.

I still question if TEVA or Amphastar would be required to meet the same standard of analysis. These companies must have received guidance for the application that contained metrics for the equivalence of their products with Lovenox. So long as they meet these requirements shouldn't they also receive approval?

Put another way:
Would the FDA say after they have given out guidance that the requirements have changed and request of TEVA etc the MNTA type of analysis?

Or is the FDA held to the guidance it put forth originally?

I could see how the FDA would want to apply the highest standard of analysis to the generic which would seem to be a big advantage to MNTA in this case.