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linhdtu

10/14/11 7:04 PM

#128489 RE: DewDiligence #128488

Ampha is cooked. I expect them to be dragged , kicking and screaming , into complying with the judge's order.

zipjet

10/14/11 7:27 PM

#128494 RE: DewDiligence #128488

release testing related to detecting 1,6-anhydro ring structures



If I understand this, the 1,6-anhydro ring is a key patent claim of MNTA.

The fact that Ampha is resisting this request even AFTER the judge orders it, offers a positive inference.

:-)

ij

go seek

10/15/11 3:17 PM

#128531 RE: DewDiligence #128488

The items that Amphastar must produce on or before 10/17/11 include the following sections of Amphastar’s ANDA: i) release testing related to detecting 1,6-anhydro ring structures; ii) release testing related to sequencing of tetrasaccharides; and ii) master batch records.


What is the likely scenario if / when Momenta complains and the court agrees that the items were not provided as requested?