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

To: tuck who wrote (2516)	9/28/2010 8:55:10 PM
From: DewDiligence_on_SI	Respond to of 3027

Agreed that this meeting has little or no consequence for MNTA in the short run. FWIW, I assume that the first few FoB’s approved by the FDA under the new regulatory pathway will require at least one clinical trial to show safety and efficacy. Eventually, the FDA might be willing to entertain a Lovenox-like approval for a protein drug where the review does not include a clinical trial, but I think it will take at least a few years for the FDA to get comfortable with this idea. *Provided that it was characterized by MNTA :-)

To: tuck who wrote (2516)	5/15/2011 2:17:02 PM
From: tuck	1 Recommendation Respond to of 3027

More color on the FDA's current thinking regarding biosimilars (hat tip to jq1234 of IHub): biocentury.com "Behrman, who is associate director for medical policy in the Center for Drug Evaluation and Research, said the agency will spell out in a series of guidance documents how it will implement a two-step approach to reviewing biosimilars. At least one guidance will be released before year end, she said . . ." If only the first in a series of guidance documents is going to make it out this year, that suggests it will be well into next year, at best, before the FDA's thought process on this subject is completely known. This in turn continues to suggest to me that a FOB partnership for MNTA is not coming this year. That said, the process as we currently know it would appear to play to MNTA's strengths. Cheers, Tuck