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Replies to #79342 on Biotech Values
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bladerunner1717

06/10/09 9:25 AM

#79344 RE: iwfal #79342

"On the legislation we'll introduce later today, there are some gaps in it and done so intentionally," said Dodd at a press conference earlier Tuesday. "There are no gaps in our determination, in my determination and that of my colleagues to have a public option, to have something done with the pay or play and deal with the follow on biologics. But I left those areas open for discussion, not because they're open for some sort of decision about whether or not we ought to move in that direction. But I want my Republican colleagues to know, I want their ideas, I want to hear what they have to say. This is a bill, it's an opening step."


It struck me as quite significant that Sen. Dodd, highest ranking Democrat on the Committe next to Ted Kennedy, would put "follow on biologics" in the same class of importance as the "pblic option" and "pay or play" provisions.


Bladerunner
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DewDiligence

06/10/09 3:27 PM

#79359 RE: iwfal #79342

MNTA: I need to listen to the cc - but would point out that FDA acceptance of MNTA's technology as a troubleshooter (being able to find a large body of mismatches that no other technology could find) is a significantly different thing than acceptance that there are No/none/nada/zilch/zip mismatches of clinical significance that could escape detection.

My comments in #msg-38561800 have nothing to do with MNTA’s troubleshooting of the contaminated heparin from China; rather, the comments apply to the progress of the Lovenox ANDA itself and the observation that assuring the integrity of the bulk-heparin supply chain appears to be the sole remaining roadblock to approval of the ANDA.