Biotech Values

[mcbio]

Re: MNTA (FDA comments)

FDA Deputy Commissioner Joshua Sharfstein said late Thursday that Momenta's scientists were brought into the Chinese heparin crisis because of their expertise. He said helping the agency address a public-health crisis shouldn't preclude a company from applying for a drug approval. Mr. Tyler said such issues "can't handcuff the agency for all time" in reviewing a company's drug application.

The FDA staff citing its sole use of MNTA for its "expertise" during the heparin crisis strikes me as a fairly bullish sign for MNTA. If FDA staff views MNTA as having expertise, I don't think it's unreasonable to think that MNTA's generic Lovenox is likely being viewed in a better light by the FDA compared to the competition. That just strikes me as pretty obvious.