Replies to post #12276 on Momenta Pharmaceuticals, Inc. (MNTA)

[DFRAI]

Dewdiligence

Any comment/observation on today's call?

This board has speculated on the two baxter molecules being humira and orencia...is this not known to the investment community?

[DewDiligence]

how likely is that fda would request additional info at this point? Approval 99.9%?

An additional FDA request for data at this point is highly unlikely, IMO. (The FDA’s gene-expression request was satisfied by MNTA in early May.) I think the probability of FDA approval by the end of 2014 is about 85%.

[DewDiligence]

Lovenox....it seems based on reading that District Court/Federal court should reverse their ruling - otherwise the entire profitability of generic companies is in question. Since Momenta will not go after FDA...what are the chances at this point for FDA/DOJ to assist MNTA in winning this battle of safe harbor application for only pre-approval actions. What are the chances for injunction against Amphastar and Teva and getting damages? or Royalty?

It’s conceivable that MNTA could still obtain Lovenox damages from patent infringement by Amphastar, but this possibility is too remote for me to ascribe any value to it. The more pressing concern, IMO, is whether MNTA will have to forfeit its $35M portion of the $100M bond posted by NVS/MNTA when an injunction against Amphastar was obtained in 2011 (until the CAFC lifted the injunction in Jan 2012).

[DewDiligence]

IND for M923 in second half - I seem to recall a 12-24 month approval on these FOB's, correct?

No one knows how long it will take for the FDA review of 251(k) applications because the first such application was just made a few days ago. In any case, it will be at least a couple of years form the start of phase-1 trial for M923 until a 351(k) submission can be made.

p.s. Technically, MNTA is filing a CTA for M923 rather than an IND; CTA is the term used in Europe, where the phase-1 trial of M923 will be conducted.