Biotech Values

[stockdak]

MNTA technology

Although MNTA acted to analyze the contaminated heparin samples in their labs I don't believe they necessarily have a technological advantage compared to TEVA. IMO the mass spectrometry and chromatography methods to perform this analysis are no secret. Rather having the expertise to perform this assay routinely and analyze the results in a facile manner is the competitive advantage. MNTA has demonstrated that this assay is up and running with their collaboration with the FDA.

Does this mean that TEVA and Amphastar cannot analyze their generics to the same level as MNTA? Maybe, maybe not.

Does it matter for ANDA approval?
From the TEVA website: "To be considered bioequivalent to its innovative counterpart, a generic drug must not only have the same active pharmaceutical ingredient, but the rate and extent of absorption of its active ingredient into the bloodstream must also be the same or similar, within ranges designated and approved by the relevant regulatory health authority."

So long as the equivalence metrics are met all the companies could receive approval. I am not counting TEVA out.

FYI I have not sold any of my MNTA shares acquired at <$5 PPS. Longer term M118 has alot of promise. Short term they may be bought out by NVS.