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1234jklm

06/15/18 9:55 PM

#84378 RE: purplehp #84377

Purple isn’t it impressive that pmcb is managing and succeeding at all these tests

This company has changed so much in the last six months.

I think Thomas Yuen has a lot to do with it too.

He has a history of buying new technology and turning it into zillion dollar products.

Wolfy3

06/16/18 7:17 AM

#84380 RE: purplehp #84377

I don’t have a lot of experience in IND filing but have an understanding of FDA requirements from years of working on the production side - when we changed to serum free media we had to requalify our process which included 5 full scale production runs a lot of testing and re file for approval with FDA EMA etc and had to get that approval before marketing the product- you basically can’t change anything without agency review and approval. hope that helps?