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Biotech / Medical : Dynavax DVAX -- Ignore unavailable to you. Want to Upgrade?


To: fred hayes who wrote (96)2/20/2013 11:39:51 AM
From: mopgcw  Respond to of 184
 
appreciate your insights as always, obviously i agree, and was actually thinking of adding another slug here on this downdraft.



To: fred hayes who wrote (96)2/20/2013 2:09:42 PM
From: scaram(o)uche1 Recommendation  Read Replies (1) | Respond to of 184
 
Panel Chair was straight out of Twilight Zone.

The traditional FDA view of new adjuvants and new cell platforms for the production of vaccines?

(only the first being relevant here)

Thou shalt go to hell and back, and then add 10 years. Imagine a lung surfactant, ten times pain in ass. That was the FDA of 1990...... honchos really go through agony re. new adjuvants.

Adjuvants need to keep up and we can't leave the hoop jumping exclusively to deep-pocket pharmas. Some on the panel seemed almost offended that little DVAX would wander into the Realm.



To: fred hayes who wrote (96)2/21/2013 10:10:10 AM
From: fred hayes1 Recommendation  Respond to of 184
 
Jefferies came out with a note today saying fda won't approve due to lack of need (other vaccines available) and expects a crl. Still predicts eventual approval. Maybe I'm too optimistic here with my 75 percent guess. Still, I think this case stands out as an obvious panel screwup. There's a link to the Jefferies note over on Dew's board.