Biotech Values

[iwfal]

They’re confirming that the work related to immunogenicity begun in 2007 was a minor amendment to the Lovenox ANDA

Note that MNTA IR was very specific wrt "Minor Amendment" was filed (but that letter to them was not "Minor Deficiencies" letter).

However it appears to be generally true that the FDA correlates the two - i.e. "Minor Deficiences" are those things that result in "Minor Amendments" and "Major Deficiencies" are those things that result in "Major Amendments".)

Not conclusive - but reasonable dotting of the 'i's.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072888

(above link is same guidance from which HPT quoted)