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

To: tuck who wrote (2857)	10/2/2011 1:22:26 PM
From: mopgcw	1 Recommendation Respond to of 3027

nice dig. Thanks for sharing.

To: tuck who wrote (2857)	10/3/2011 8:22:27 AM
From: IRWIN JAMES FRANKEL	Respond to of 3027

>>Obviously, a is bad for Momenta and b is good. Is it realistic to think that there could be a "one shoe fits all" solution? Seems to me that is not what we are looking for. Rather, we should expect a framework by FDA into which they can insert details necessary for evaluating various products as they are presented. But the framework will be a real advance and set the stage for advancing the complex. JMHO ij

To: tuck who wrote (2857)	11/16/2017 7:56:56 PM
From: tuck	Respond to of 3027

CMS proposals on various topics out today. Of interest to MNTA - should they ever launch a biosimilar - is the proposal to categorize them for low income patient subsidies, i.e. as generics. To whit: "Treatment of Follow-On Biological Products as Generics for Low Income Subsidy (LIS) Cost Sharing and Non-LIS Catastrophic Cost Sharing This provision would further encourage the use of lower-cost alternatives by classifying follow-on biological products as generics for the purposes of cost-sharing for Part D enrollees who do not receive the LIS and are in the catastrophic portion of the benefit, and for LIS Part D enrollees throughout all phases of the benefit." CMS proposals This, of course, has nothing to do with the drug approval process for follow-ons. Cheers, Tuck