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

To: idos who wrote (2478)	9/7/2010 3:30:55 PM
From: tuck	1 Recommendation Read Replies (2) \| Respond to of 3027

I have to agree with Dew here: the FDA must have had some way around this in mind to accept an ANDA, as this in vivo/in vitro assay issue was known before the FDA accepted it. Anyhow, so the motion for summary judgement is denied, meaning the case will probably go to trial. Our friend the Bernstein analyst figures this means 2012 at earliest for a generic Copaxone to get through, and that seems reasonable. Probably the reason Momenta rebounded today, though, was the same analyst's assertion that the Copaxone patents are vulnerable on the prior art/obviousness issue, i.e. that they are too much based on the expired 350 patent. This guy Ronny Gal seems to be the axe in the name for now. I managed to pick up some cheap options due to a lowball limit order I had in, and now have a nearly full position again. Feel free to partner something now, Momenta. Cheers, Tuck

To: idos who wrote (2478)	9/14/2010 4:28:25 AM
From: tuck	Read Replies (1) \| Respond to of 3027

Re: "Copolymer Assay" Notable excerpt: "The present invention provides methods and compositions for evaluating one or more properties of a candidate agent (e.g., an amino acid copolymer, e.g., Copolymer-1; e.g., glatiramer acetate). In one aspect, the invention provides a variety of embodiments for evaluating an amino acid copolymer preparation for physiological, pharmacodynamic, pharmacokinetic, or pharmaceutical properties including but not limited to potency, specificity, stability, biological activity, e.g., for suitability as a pharmaceutical preparation, e.g., for the treatment of autoimmune and/or inflammatory disease, disorders or dysfunctions." Although, looking at this, I see it's all in vitro, and I don't see the embodiments relating to PK and PD, that is, if they are there, I am not recognizing them as such. Would the FDA go for this? wipo.int Cheers, Tuck