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Replies to #84904 on Biotech Values
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rkrw

10/12/09 12:07 PM

#84905 RE: genisi #84904

Not as if you can do a trial C1 vs placebo for laryngeal attacks :)Shouldn't they have open label data on various attacks? Does it indicate anywhere that they did receive orphan status?
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DewDiligence

10/12/09 5:55 PM

#84948 RE: genisi #84904

VPHM CSL:

Makes sense the FDA wants 2 products in the market…

The FDA’s actions in this case vis-à-vis orphan exclusivity are questionable from a scientific standpoint, IMO.

If VPHM and CSL were thinking outside the box, they could outflank the FDA’s rulings by agreeing to co-market both drugs, which would be more efficient for the sales reps from both companies. (The company with the more valuable drug from a commercial standpoint could receive a kicker to make the co-marketing deal equitable.)