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Biotech / Medical : Momenta Pharmaceuticals Inc. -- Ignore unavailable to you. Want to Upgrade?


To: tuck who wrote (162)7/31/2006 12:19:40 PM
From: dr.praveen  Respond to of 3027
 
I agree tuck. They r not that good on deadlines. I don't know what their problems are...:-( :-) I feel M118 is a very big opportunity for Momenta which is behind schedule. Also they didn't give out the time frame for the filing of their mystery generic.

Having said all that, I will be very patient on them.

Regards,
Praveen



To: tuck who wrote (162)7/31/2006 12:56:32 PM
From: rkrw  Read Replies (3) | Respond to of 3027
 
Lovenox filing they guided to mid 05 and they filed in August 05. So less so late than stressful to shareholders since it wasn't June or July.

118 they reguided to filing mid this year not long after the ipo. See below.

This is complex stuff, characterizing and reverse engineering the mfg process and making sure you can replicate to scale, so I think it's a lot harder than typical to guide.

Not that I like missed timelines less than anyone else. But I'm happy they got it into the clinic since I think there's sound basis for why it should work and become one of the major unpartnered biotech programs. But it's cv, will take a lot of time and money!

Recent Developments

Nov 2004:

<<M118, the Company’s preclinical novel low molecular weight heparin candidate targeted for acute coronary syndromes, is currently in preclinical development. The Company has made a strategic decision to develop an alternate manufacturing process for M118 now rather than waiting until a later stage in the product’s clinical development. This process development effort is intended to result in a more efficient and reproducible process for manufacturing the drug substance required for future clinical and commercial programs and has the potential to reduce near-term development costs for M118. Development of the alternate manufacturing process is anticipated to cause a six to twelve month delay in the filing of the IND for M118 from the Company’s previously disclosed target filing date of June 2005.>>

Well, 6-12 month delay turned out to be 13. Not too too bad :-)