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Biotech / Medical : Indications -- Psoriasis/Chronic Inflammation -- Ignore unavailable to you. Want to Upgrade?


To: scaram(o)uche who wrote (265)9/12/2002 11:06:18 PM
From: aknahow  Read Replies (1) | Respond to of 631
 
Rick, do you mean BGEN made a prior reply to the FDA's request for a complete response? I did think the FDA was obligated to respond in six months, just not obligated to approve the drug.

"
Putting all of the BS aside..... this is a resubmission, addressing major deficiencies. Moreover, the response OBJECTIVE is within six months,
but FDA is not obligated to meet it."



To: scaram(o)uche who wrote (265)9/13/2002 10:29:38 AM
From: software salesperson  Read Replies (1) | Respond to of 631
 
Rick,

But, IMO, there's been little in the way of biological insight behind the clinical testing.

could you explain what you mean more specifically? thx.

sales