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Biotech / Medical : momo-T/FIF -- Ignore unavailable to you. Want to Upgrade?


To: Biomaven who wrote (5916)3/29/2007 1:49:23 PM
From: former_pgs  Read Replies (1) | Respond to 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.



To: Biomaven who wrote (5916)3/30/2007 1:05:50 AM
From: pgo-neil  Respond to of 12215
 
I checked a few other immune / active cell companies for after hour's responses in sympathy to the DNDN AC. THey all seemed pretty healthy. AGEN 13%, BIOM 17%, CEGE 26%, FVRL 4%, GTOP 16%... If the market is euphoric enough it might build on those positives for a few days. Hopefully it should sweep DNDN along for a few points now before returning to the questions of FDA action, manufacturing, and market acceptance [although I think that should do pretty well].

At $5 and change, the shorts could muscle with it until it becomes the next big thing on a TV program. Mike Huckman says it could lift off, so it that gets repeated, the meme just might overcome current market forces and establish a new one. [I hope.]

Best,
graham
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