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Re: biotech_researcher post# 17109

Friday, 04/21/2017 10:05:59 AM

Friday, April 21, 2017 10:05:59 AM

Post# of 20689
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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