Biotech Values

[iwfal]

Corollary: The FDA has evidently accepted that MNTA’s characterization technology can fully characterize the active ingredients in Lovenox and that NVS/MNTA’s response to the FDA’s questions on immunogenicity are sufficient.

I need to listen to the cc - but would point out that FDA acceptance of MNTA's technology as a troubleshooter (being able to find a large body of mismatches that no other technology could find) is a significantly different thing than acceptance that they are No/none/nada/zilch/zip mismatches of clinical significance that could escape detection.

PS As you have pointed out many times for other companies - the characterization of the FDA status by the company is often mistaken.