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Biotech / Medical : momo-T/FIF

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To: Biomaven who wrote (5916)	3/29/2007 1:49:23 PM
From: former_pgs	Read Replies (1) of 12215

>I always had a manufacturability concern as well that may start to become an issue down the road if they do get approval.< I agree with this, but it's very confusing as well. Given that the treatment does not elicit an immune response against the intended antigen (PAP) or the leading sequence in the chimera (GM-CSF), but rather only reacts to the gm-csf - PAP chimera, I'm not sure what the FDA could ask? This treatment is such a black box that even if the FDA had manufacturing concerns, there is little data available to them to turn around and tell the company "you need to get X up to a certain level Y". This is a very interesting panel. You have a drug with a mixed efficacy package and a manufacturing process that is very difficult to pin down.

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