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Puffer

11/22/12 12:48 PM

#63938 RE: daBoze #63937

I think the answer can be gleaned from this response by Dr. Seymour to leifsmith --

GS: Clinical trial material will be done on GMP-like materials (GMP lab specs but the plant just won't have been inspected and registered with the FDA)



I think this is clearly referring to the Shelton plant before it is FDA certified. Or perhaps an outside lab. The statement "won't have been" refers to a future lab capability, not their existing lab. I think they are using the same material from the same source for all clinical phases. I would be happily corrected though.
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leifsmith

11/23/12 10:00 AM

#63945 RE: daBoze #63937

Agree except that I'm not sure the GLP cides will be produced by the company. I think that may be contracted. But ... I really have no solid info ...