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DFRAI

04/21/17 10:05 AM

#17110 RE: biotech_researcher #17109

If same plant but different production line for 20 ml copaxone...is allowed to continue, a few questions

1. Plant violations affect new approvals only - setting up new production lines?
2. I presume that Pfizer would set up a new line for the 40ml and have it inspected by FDA - could this happen if the plant had "other general" violations?
3. I would stop the 20ml production line and convert it to 40ml and go after the 80% of the market if possible.

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DewDiligence

04/21/17 11:10 AM

#17112 RE: biotech_researcher #17109

20mg and 40mg use the same production line, according to MNTA's 4Q16 CC (#msg-128865663).