Replies to post #16818 on Momenta Pharmaceuticals, Inc. (MNTA)

[mouton29]

I'm guessing it will be in this area of the FDA website,
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm538552.htm#OMQ

In the meantime, we can amuse ourselves by reading letters other manufacturers have received.

[mouton29]

If the Seeking Alpha transcript is to be believed, Craig Wheeler said the letter might be available "maybe even starting today." So maybe today, maybe tomorrow, maybe... I'd have guessed it would take some time to redact the letter, but Wheeler also said that Momenta had seen a redacted copy, so presumably the redactions are done

Craig Wheeler

Sure, Dana. Thanks. This is Craig. I can’t really provide a lot of color on the nature of the deficiencies at this time, since we’re under confidentiality, and those observations were not on our product. So, they’re just general observations. However, that redacted letter should be available, maybe even starting today at the FDA. And once it’s public, we can talk more about it, but until that point in time, we’re under confidentiality with Pfizer. But, you should be able to get clarity on that soon, just directly from the FDA.