Replies to post #107802 on Biotech Values

[go seek]

MNTA's turn tomorrow
November 3, 2010 10:50 AM ET

Oppenheimer & Co. Inc. 21st Annual Healthcare Conference

http://ir.momentapharma.com/eventdetail.cfm?EventID=87684

[dewophile]

why would the application need to go through this office if it is being handled at the FDA as a traditional generic?
did MNTA's application go through this office as well?

[Regulardoc]

The question to ask MNTA/Wheeler is whether or not the m-enox ANDA went to the Office of Biotechnology. If not, (and while it could go both ways) I would surmise that given the litigiuos environment, the FDA may want two separate opinions that support a denial.

As far as "sameness'" I think they are throwing this term around beyond the FDA intent. I don't think anyone disputes that t-Lovenox is an effective anticoagulant, but is it the "same" as m-enox. Most likely it is not.

Additionally, if the ANDA now sits in a different division, they ain't close to approval.

[HattieTheWitch]

Marth claims the ANDA is now at the FDA’s Office of Biotechnology Products...to assess immunogenicity, and he implies that this means the drug has achieved sameness to branded Lovenox...

A couple of quibbles if I may...

Marth evidently mangled the name of the section because he said OPB, not OBP.

Also, he didn't state that the meeting with OPB meant that they had established sameness (unless OPB is "management"), he made the mention of establishing sameness prior to his mention of OPB.

See my post 107820 for a link to the audio (@ 57:05).

I hope you can untangle the matter!